Postoperative Complications and Axial Length Growth after Bilateral Congenital Cataract Surgery: Eyes with Microphthalmos Compared to a Comparison Group

doi:10.21203/rs.3.rs-3398936/v1

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Postoperative Complications and Axial Length Growth after Bilateral Congenital Cataract Surgery: Eyes with Microphthalmos Compared to a Comparison Group

https://doi.org/10.21203/rs.3.rs-3398936/v1

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published 21 Jun, 2024

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Purpose: To investigate the postoperative clinical outcomes and axial length (AL) growth of infants with congenital cataracts and microphthalmos following first-stage cataract surgery.

Design: Retrospective case control study

Methods:

Setting: Single center.

Infants with congenital cataract that met the inclusion criteria were classified into two groups: the microphthalmos and comparison groups. All infants underwent a thorough ophthalmologic examination before surgery, and one week, 1 month, 3 months, and every 3 months after surgery.

Results: This study enrolled 21 infants (42 eyes) in the microphthalmos group and 29 infants (58 eyes) in the comparison group. More glaucoma-related adverse events were observed in the microphthalmos group (7 eyes, 16.7%) than in the comparison group (0 eyes, 0%) (p<0.001). At each subsequent follow-up, the comparison group had a greater AL than the microphthalmos group (all p<0.001), and AL growth was significantly higher in the comparison group than in the microphthalmos group (all p=0.035). Visual acuity improved in both groups.

Conclusion: Early surgical intervention improves visual function in infants with congenital cataracts and microphthalmos although with a higher incidence of glaucoma-related adverse events. After cataract removal, the AL growth of microphthalmic eyes is slower than that of normally developed eyes.

Health sciences/Diseases/Eye diseases/Lens diseases

Health sciences/Diseases/Eye diseases

Microphthalmos is a rare structural eye malfunction resulting from abnormalities in the development of the primary optic vesicle.¹ It has an incidence of 0.2–9 per 10,000 births, affects 3–11% of blind children, and is associated with a high prevalence of congenital cataracts.^2–5 Microphthalmos has been described as eyes with an axial length (AL) 2 standard deviations below the age-adjusted mean,⁶ typically resulting in an AL below 20.5 mm in adult eyes.^{7, 8}

In infants with congenital cataracts, early cataract surgery is essential to prevent amblyopia and improve visual functions. Although pediatric cataract surgery techniques and postoperative management have consistently improved in recent years, postoperative complications remain important factors that may obstruct visual rehabilitation. Multiple studies have reported the incidence of postoperative complications after congenital cataract surgery. In postoperative glaucoma, Zhang et al.⁹ reported that the incidence of glaucoma-related adverse events was 8.10% during a 4-year follow-up. Wang et al.¹⁰ observed that the cumulative incidence of suspected and definitive glaucoma was 9.97% during a 5-year follow-up.

For pediatric ophthalmologists, surgeries on infants with microphthalmos can be more challenging because of the crowded anterior segment and the high risk of intraoperative and postoperative complications. In a 37-year longitudinal follow-up, Belitsky et al.¹¹ reported that the total glaucoma prevalence was 14.8%, including late- (10.7%) and early-onset (4.1%) glaucoma, and that most patients with late-onset glaucoma had microphthalmos. Although various postoperative complications (glaucoma-related adverse events, visual axis obscuration, and posterior synechiae) have been reported in previous studies which investigated clinical outcomes after congenital cataract surgery, a minority of them focused on microphthalmic eyes. On the other hand, different definitions of microphthalmos and complications might have affected the results, and most of them did not include a comparison group.

AL development is an important factor affecting prognosis, close to selection of an appropriate timing and target refraction of second-stage intraocular lens (IOL) implantation. However, AL growth after first-stage cataract surgery (cataract removal) has been disputed in previous studies due to different study populations and follow-up periods. In rare cases of microphthalmos, AL growth has not been well studied, and the comparison between children with and without microphthalmos in the same age group requires further study.

Therefore, we investigated the postoperative clinical outcomes and AL growth of infants with congenital cataracts and microphthalmos following first-stage cataract surgery and compared these results with those of contemporary infants without microphthalmos to evaluate postoperative complications and benefits from surgery. Analysis of the postoperative AL growth in the two groups helped us understand the developmental trends of microphthalmic eyes.

2.1 Patients selection

This retrospective study enrolled infants with bilateral congenital cataracts who underwent lensectomy combined with limited anterior vitrectomy without primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou Branch) between January 2016 and October 2020. This retrospective study was approved by the Institutional Review Board/Ethics Committee of Wenzhou Medical University (Optometry Hospital of Wenzhou Medical University, 2021-051-K-43). This study was conducted in accordance with the tenets of the Declaration of Helsinki. Legal guardians of pediatric patients signed informed consent before their being included in the study.

The inclusion criteria were as follows: (1) bilateral congenital cataract, (2) all surgical procedures performed by the same ophthalmologist (Yun-e Zhao), (3) age at surgery ≤ 12 months, and (4) followed up for ≥ 12 months. The exclusion criteria were as follows: (1) eyes concurrent with glaucoma, uveitis, retinopathy of prematurity, traumatic cataract, aniridia, steroid-induced cataract, posterior persistent fetal vasculature causing stretching of the ciliary process, or tractional retinal detachment before surgery; (2) patients with systemic disorders such as Down's syndrome, which is independently associated with glaucoma¹² and probably causes growth retardation, and Marfan syndrome; and (3) history of previous ocular surgery.

All patients were classified into two groups: the microphthalmos and comparison groups. Microphthalmos was defined as a total AL at least two standard deviations below the mean age,^{6, 13} equating to 19.2 mm at 1 year and 20.9 mm at adulthood.¹⁴ The microphthalmos group was further classified into the microcornea group (horizontal corneal diameter < 9.0 mm) and the relative normal-size cornea group (horizontal corneal diameter ≥ 9.0 mm).

2.2 Surgical technique

All surgeries were performed by the same experienced congenital cataract surgeon (Yun-e Zhao) under general anesthesia using the Accurus or Centurion system (Alcon Laboratories, Inc., Fort Worth, TX, USA) with a cut-rate of 2,000 per minute and vacuum of 350 mmHg. Two 0.8-mm precise corneal incisions were created at 10 and 2 o’clock using a MANI ophthalmic knife (MANI, Inc., Tochigi, Japan); lens aspiration was performed after anterior vitrectorhexis with a diameter of about 4.5–5.0 mm, followed by posterior vitrectorhexis about 3–3.5 mm and limited anterior vitrectomy with a 23-gauge vitrector and 23-guage irrigating cannula via two cornea incisions. The incisions were closed using 10–0 absorbable Vicryl sutures (Ethicon, Somerville, NJ, USA). Peripheral iridectomy was performed prophylactically in several cases to decrease the possibility of a pupillary block and inflammatory peripheral anterior synechiae. Without primary IOL implantation, all patients remained aphakic after surgery. The interval between the binocular surgeries was within 7 days.

Postoperative topical treatment included levofloxacin (0.5%) eye drops four times a day for two weeks, tobramycin dexamethasone eye ointment once a day for two weeks and tobramycin dexamethasone eye drops four times a day, which were tapered for four to six weeks postoperatively. Atropine (1.0%) was administered once a day for 1 week and later changed to tropicamide phenylephrine eye drops (Mydrin®-P) once a day for one month. Optical correction using aphakic spectacles was prescribed for all patients.

2.3 Primary outcome measures

All pediatric patients underwent a thorough ophthalmologic examination before surgery, and one week, 1 month, 3 months, and every 3 months after surgery. The examination included slit-lamp bio-microscopy, dilated fundus examination, A-scan ultrasound examination (Axis Nano, Quantel Medical, Cournon, France), and estimation of IOP (iCare, Vantaa, Finland).

2.3.1 Ocular biological parameters and demographic features

AL, anterior chamber depth (ACD), and lens thickness (LT) were measured using an contact ultrasonic A-scan (Axis Nano, Quantel Medical, Cournon, France) under sedation. The horizontal corneal diameter (HCD) was measured at the beginning of surgery using calipers. IOP was evaluated using an iCare (Vantaa, Finland) rebound tonometer under anesthesia, if not cooperatively. Furthermore, AL, ACD, and LT were measured 10 times, and IOP was measured 6 times for each eye; the mean values were recorded. All the measurements were performed by the same technician.

All surgical videos were reviewed by three experienced congenital cataract doctors (Y.E.Z., Y.Y.Z., D.D.W.) to identified preexisting posterior capsule defects (PPCD), which included 3 types of PPCD. Type I showed large defect with sinking cortex in anterior vitreous, type II cluster of fibrotic spots in posterior capsule, and type III with concurrent persistent fetal vasculature (PFV).¹⁵

2.3.2 Visual function assessment

Before surgery, due to the young age (< 12 months) and poor cooperation, an objective visual assessment was not possible. In the subjective evaluation, we classified infants’ visual function into inability, instability, and stability of fixation, depending on their ability to fixate on or follow a light source or toys of different colors, and the results were recorded.

After surgery, patients with poor cooperation were assessed in the same manner as described above, and the two results were compared. The Teller acuity card (Stereo Optical Co., Inc., USA) procedure was performed on cooperative patients by the same technician. Visual acuity was recorded at the patient’s last follow-up.

2.3.3 Postoperative complications

The main postoperative complications were glaucoma-related adverse events, posterior synechiae, and visual axis opacification (VAO).

According to the IATS¹⁶ and the Childhood Glaucoma Research Network (CGRN)¹⁷, glaucoma-related adverse events were defined as glaucoma plus glaucoma suspect. A study eye was diagnosed as having glaucoma if the IOP was > 21 mmHg with one or more of the following anatomical changes: (1) corneal enlargement; (2) asymmetrical progressive myopic shift coupled with enlargement of the corneal diameter and/or AL; (3) increased optic nerve cupping defined as an increase of ≥ 0.2 in the cup-to-disc ratio; or (4) a surgical procedure was performed for IOP control. A study eye was diagnosed as a glaucoma suspect if there were either (1) recordings of two consecutive IOP measurements > 21 mmHg on different dates after topical corticosteroids had been discontinued without any of the anatomical changes listed above for glaucoma, or (2) glaucoma medication was used to control IOP without any of the anatomical changes listed above.

The existence of posterior synechiae was evaluated using slit-lamp microscopy and defined as adhesion of the posterior iris plane and the margin of the anterior vitrectorhexis or pupil deformation. The VAO examination consisted of retroillumination with slit-lamp microscopy. Any obscuration of the visual axis area requiring an Nd:YAG laser¹⁸ or surgical intervention was recorded as VAO.

2.4 Statistical analysis

All statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were used to analyze individual- and eye-level characteristics. The normality of data distribution was analyzed using the Kolmogorov-Smirnov test, and abnormalities in data distribution were analyzed using non-parametric statistical analyses. Values are expressed as the mean ± standard deviation (SD), range, or median (interquartile range [IQR]). The Mann–Whitney U-test, Chi-Square Test, or UNIANOVA was employed to compare the parameters among the different groups. The Chi-square test, Fisher’s exact test or generalized estimating equation (GEE) was used to compare the differences in complication incidence between the different groups. The UNIANOVA or GEE was used to adjust binocular correlation influence. A GEE was used to adjust for the difference in AL and AL increments between the different groups in each postoperative period. Logistic regression analysis was used to analyze potential risk factors for postoperative complications, generating odds ratios (ORs) and associated 95% confidence intervals (CIs). Statistical significance was set at p < 0.05.

3.1 Demographic features and ocular characteristics

This study enrolled 21 infants (42 eyes) in the microphthalmos group and 29 infants (58 eyes) in the comparison group. Demographic features and ocular characteristics of the patients are shown in Tables 1a and 1b. The mean age at surgery of the microphthalmos group was 4.09 ± 1.87 months, and the mean follow-up duration was 34.96 ± 12.65 months. While in the comparison group, the mean age at surgery was 4.84 ± 2.08 months, and the mean follow-up duration was 30.50 ± 9.28 months. The preoperative AL was 16.60 ± 0.82 mm in the microphthalmos group, as compared to 18.77 ± 0.94 mm in the comparison group (Fig. 1). The differences in preoperative AL (p < 0.001), LT (p = 0.021), HCD (p < 0.001), intraoperative dilated pupil size (p < 0.001) and last follow-up IOP (p < 0.001) between the two groups were statistically significant. Other features, including sex (p = 0.416), family history of congenital cataracts (p = 0.741), preoperative IOP (p = 0.196), mean age at surgery (p = 0.068), follow-up duration (p = 0.125), and ACD (p = 0.376), were similar between the two groups.

Table 1

a Demographic features (individual-level characteristics)
	The microphthalmos group	The comparison group	p-value
Patients (n)	21	29
Sex (Male/Female)	16/5	19/10	0.416^b
FHCC (n, %)	4, 19.0%	7, 24.1%	0.741^c
Mean age at surgery (month)	4.09 ± 1.87 (1.7−8.0)	4.84 ± 2.08 (1.2–11.0)	0.068^a
Follow-up duration (month)	34.96 ± 12.65 (16.0−58.3)	30.50 ± 9.28 (17.9–59.2)	0.125^a
^a Mann–Whitney U Test, ^b Chi-Square Test, ^c Fisher’s Exact Test
FHCC, Family history of Congenital Cataracts.

Table 1

b Ocular characteristics (eye-level characteristics)
	The microphthalmos group	The comparison group	p-value
Eyes (n)	42	58
Pre-op ocular characteristics
AL (mm)	16.60 ± 0.82 (15.05–18.35)	18.77 ± 0.94 (16.18–21.10)	< 0.001^a
HCD (mm)	8.75 ± 0.97 (6.5–10.5)	9.77 ± 0.67 (8.2–11.5)	< 0.001^a
LT (mm)	2.86 ± 0.87 (1.56–5.11)	3.47 ± 1.17 (1.76–6.33)	0.021^a
ACD (mm)	2.35 ± 0.48 (1.81–3.93)	2.48 ± 0.50 (1.83–3.97)	0.376^a
IOP (mmHg)	10.88 ± 2.42 (6.0–15.0)	11.76 ± 2.34 (6.0–17.0)	0.196^a
Intra-op dilated pupil size (mm)	5.25 ± 1.09 (2.92–7.66)	6.62 ± 0.89 (4.26–7.85)	< 0.001^a
Last follow-up IOP (mmHg)	15.90 ± 2.74 (12.0–21.0)	14.03 ± 2.24 (6.4–18.5)	< 0.001^a
Microcornea (n, %)	21, 50.0%	5, 8.6%	< 0.001^b
PPCD (n, %)	24, 57.1%	18, 31.0%	0.009^b
Pupilary membrane (n, %)	14, 33.3%	4, 6.9%	0.001^b
PFV (n, %)	1, 2.4%	4, 6.9%	0.395^c
^a p-value adjusted for binocular correlation influence by UNIANOVA, ^b Chi-Square Test, ^c Fisher’s Exact Test
Pre-op, Preoperative; AL, Axial length; HCD, Horizontal corneal diameter; LT, Lens thickness; ACD, Anterior chamber depth; IOP, Intraocular pressure; Intra-op, Intraoperative; PPCD, Preexisting posterior capsular defect; PFV, Persistent fetal vasculature.

In the microphthalmos group, 21 eyes (50.0%) had combined microcorneas, 24 eyes (57.1%) had preexisting posterior capsular defects (PPCD), 14 eyes (33.3%) had pupillary membranes, and one eye (2.4%) had persistent fetal vasculature (PFV). In the comparison group, five eyes (8.6%) had microcorneas, 18 eyes (31.0%) had PPCD, four eyes (6.9%) had pupillary membranes, and four eyes (6.9%) had PFV (Table 1b).

3.2 Postoperative complications and relative risk factors

There was no significant difference in developing postoperative complications between the microphthalmos group (16 eyes, 38.1%) and the comparison group (14 eyes, 24.1%) (p = 0.646). When analyzing specific complications between the groups, more glaucoma-related adverse events were observed in the microphthalmos group (7 eyes, 16.7%; Table 2) than in the comparison group (0 eyes, 0.0%) (p < 0.001). There was no significant difference in the incidence of other complications: posterior synechiae (9 eyes, 21.4% vs. 11 eyes, 19.0%; p = 0.137) or VAO (6 eyes, 14.3% vs. 3 eyes, 5.2%; p = 0.369) (Table 3).

Table 2

Postoperative glaucoma-related adverse events in the microphthalmos group
Pt	Eye	Age at surgery (month)	Peripheral iridectomy at first-stage	Glaucoma-related adverse events	Management	Follow-up duration (month)
1	OD	3.6	No	Glaucoma suspect	Topical antiglaucoma medication	55.4
	OS	3.8	No	Glaucoma suspect	Topical antiglaucoma medication	55.4
2	OD	5.8	No	Open-angle glaucoma	Topical antiglaucoma medication	58.2
	OS	5.7	No	Open-angle glaucoma	Topical antiglaucoma medication	58.3
3	OS	2.1	No	Glaucoma suspect	Topical antiglaucoma medication	43.5
4	OD	1.8	No	Secondary angle-closure glaucoma	Topical antiglaucoma medication + Surgery	51.5
	OS	1.7	No	Secondary angle-closure glaucoma	Topical antiglaucoma medication + Surgery	51.7

Table 3

Incidence of postoperative complications in the two groups
	The microphthalmos group(n = 42)	The comparison group(n = 58)	p-value*
Glaucoma-related adverse events (n)	7 (16.7%)	0 (0%)	༜0.001
Posterior synechiae (n)	9 (21.4%)	11 (19.0%)	0.137
VAO (n)	6 (14.3%)	3 (5.2%)	0.369
Eyes with postoperative complications (n)†	16 (38.1%)	14 (24.1%)	0.646
* p-value adjusted for binocular correlation influence by generalized estimating equation
† Individually included eyes with glaucoma-related adverse events, posterior synechiae, VAO, and any combination of these three postoperative complications.
VAO, Visual axis opacification.

In Table 4, the results of the logistic regression analysis were used to evaluate the potential risk factors for postoperative glaucoma-related adverse events in the microphthalmos group. In the univariate analysis, no factor exhibited significant association with glaucoma-related adverse events in the microphthalmos group (all p > 0.05), although LT provided an approximate p-value (p = 0.067).

Table 4

Univariate Logistic regression analysis of risk factors for glaucoma-related adverse events in the microphthalmos group
	Univariate Logistic regression analysis
	OR (95%CI)	p-value*
Age at surgery	1.263 (0.647–2.466)	0.494
HCD	2.403 (0.571–10.108)	0.232
ACD	1.745 (0.633–4.809)	0.281
LT	6.266 (0.880−44.631)	0.067
AL	8.309 (0.685−100.728)	0.096
Intra-op dilated pupil size	1.841 (0.672–5.045)	0.235
* p-value adjusted for binocular correlation influence by generalized estimating equation.
AL, Axial length; HCD, Horizontal corneal diameter; LT, Lens thickness; ACD, Anterior chamber depth; Intra-op Intraoperative.

3.3 The axial length growth

Excluding cases that developed glaucoma-related adverse events, AL and AL growth were compared between the microphthalmos and comparison groups at 3, 6, 12, 18, and 24 months postoperatively. At each subsequent follow-up, the comparison group had a greater AL than the microphthalmos group (all p < 0.001), and AL growth was significantly higher in the comparison group than in the microphthalmos group (all p = 0.035) (Table 5).

Table 5

Changes in AL (mm) in the two groups
	AL (mm)			AL growth (mm)
Follow-up point	The microphthalmos group	The comparison group	p-value	The microphthalmos group	The comparison group	p-value
Pre-op	16.60 ± 0.82	18.77 ± 0.94	< 0.001^a	/	/	/
3-month	17.10 ± 0.38^b	19.53 ± 0.22^b	< 0.001^b	0.36 ± 0.17^b	0.86 ± 0.12^b	0.035^b
6-month	17.56 ± 0.37^b	19.99 ± 0.22^b	< 0.001^b	0.81 ± 0.17^b	1.31 ± 0.13^b	0.035^b
12-month	18.20 ± 0.38^b	20.63 ± 0.22^b	< 0.001^b	1.39 ± 0.18^b	1.89 ± 0.14^b	0.035^b
18-month	18.66 ± 0.39^b	21.09 ± 0.23^b	< 0.001^b	1.90 ± 0.19^b	2.40 ± 0.14^b	0.035^b
24-month	19.05 ± 0.40^b	21.48 ± 0.23^b	< 0.001^b	2.26 ± 0.19^b	2.76 ± 0.16^b	0.035^b
^a p-value adjusted for binocular correlation influence by UNIANOVA, ^b values adjusted for sample size difference at every postoperative follow-up, and binocular correlation influence by generalized estimating equation

By the last follow-up, 12 of 35 eyes (excluding 7 eyes that developed glaucoma-related adverse events) in the microphthalmos group had grown to normal AL, while the other 23 eyes remained microphthalmos.

3.4 The visual function

Visual acuity improved in both groups compared to the preoperative conditions (Table 6). At the last follow-up, 27 of 42 eyes (64.3%) in the microphthalmos group gained visual acuity ≥ 0.5, whereas the comparison group showed a higher proportion, 40 of 58 eyes (69.0%).

Table 6

Postoperative decimal visual acuity outcomes*
	The microphthalmos group (n = 42)	The comparison group (n = 58)
Unable to cooperate or ≤ 0.1	5 (11.9%)	0 (0.00%)
0.1	0 (0.00%)	2 (3.4%)
0.15	0 (0.00%)	0 (0.00%)
0.2	0 (0.00%)	0 (0.00%)
0.25	4 (9.5%)	1 (1.7%)
0.3	3 (7.1%)	3 (6.5%)
0.4	3 (7.1%)	12 (20.7%)
0.5	3 (7.1%)	17 (29.3%)
0.6	24 (57.1%)	23 (39.7%)
* Tested using the Teller acuity card procedure

3.5 Microcornea eyes in the microphthalmos group

The microphthalmic eyes were divided into two subgroups according to the diameter of the cornea: the microcornea group (< 9 mm) and the normal cornea group (≥ 9 mm). Three infants (6 eyes) whose pairs were divided into different groups were excluded. As shown in Table 7a and b, there were no significant differences between the two groups in the preoperative IOP (11.32 ± 2.28 mmHg vs. 10.73 ± 2.62 mmHg; p = 0.775), mean age at surgery (3.76 ± 2.02 months vs. 4.06 ± 1.38 months; p = 0.323), last follow-up IOP (16.47 ± 2.30 mmHg vs. 15.45 ± 3.09 mmHg; p = 0.475), and follow-up duration (39.20 ± 11.58 months vs. 34.53 ± 13.23 months; p = 0.152). However, the microcornea group had smaller preoperative AL (16.12 ± 0.65 mm vs. 16.97 ± 0.66 mm; p = 0.001), LT (2.50 ± 0.64 mm vs. 3.35 ± 0.97 mm; p = 0.017), ACD (2.09 ± 0.22 mm vs. 2.56 ± 0.62 mm; p = 0.023) and intraoperative dilated pupil size (4.72 ± 1.02 mm vs. 5.91 ± 0.95 mm; p = 0.004) than the normal cornea group (Tables 7a and b).

Table 7

a Demographic features of the microphthalmos subgroups (individual-level characteristics)
	The microcornea group	The relative normal-size cornea group	p-value
Patients (n)	9	9
Mean age at surgery (month)	3.76 ± 2.02 (1.7−8.0)	4.06 ± 1.38 (2.0−6.3)	0.323^a
Follow-up duration (month)	39.20 ± 11.58 (23.3–58.3)	34.53 ± 13.23 (18.3–55.4)	0.152^a
^a Mann–Whitney U Test

Table 7

b Ocular characteristics in the microphthalmos group subgroups (eye-level characteristics)
	The microcornea group	The relative normal-size cornea group	p-value*
Eyes (n)	18	18
Pre-op ocular characteristics
AL (mm)	16.12 ± 0.65 (15.05–17.24)	16.97 ± 0.66 (15.33–17.89)	0.001
HCD (mm)	7.92 ± 0.73 (6.50–8.90)	9.58 ± 0.51 (9.00−10.50)	< 0.001
LT (mm)	2.50 ± 0.64 (1.56–4.04)	3.35 ± 0.97 (1.81–5.11)	0.017
ACD (mm)	2.09 ± 0.22 (1.81–2.55)	2.56 ± 0.62 (1.91–3.93)	0.023
IOP (mmHg)	11.32 ± 2.28 (6.70–15.00)	10.73 ± 2.62 (6.00–13.00)	0.775
Intra-op dilated pupil size (mm)	4.72 ± 1.02 (2.92–6.26)	5.91 ± 0.95 (3.50–7.66)	0.004
Last follow-up IOP (mmHg)	16.47 ± 2.30 (12.10–21.00)	15.45 ± 3.09 (12.00−20.90)	0.475
* p-value adjusted for binocular correlation influence by UNIANOVA
Pre-op, Preoperative; AL, Axial length; HCD, Horizontal corneal diameter; LT, Lens thickness; ACD, Anterior chamber depth; IOP, Intraocular pressure; Intra-op, Intraoperative.

As for postoperative complications, two groups showed no significant difference in total incidence of the three complications (9 eyes, 50.0% vs. 5 eyes, 27.8%; p = 0.746). When each postoperative complication was analyzed separately, no significant differences were observed between the two groups (all p > 0.05) (Table 8).

Table 8

Incidence of postoperative complications between the microphthalmos subgroups
	The microcornea group (n = 18)	The relative normal-size cornea group (n = 18)	p-value*
Glaucoma-related adverse events (n)	5 (27.8%)	2 (11.1%)	0.923
Posterior synechiae (n)	5 (27.8%)	2 (11.1%)	0.506
VAO (n)	5 (27.8%)	1 (5.6%)	0.881
Eyes with postoperative complications (n)†	9 (50.0%)	5 (27.8%)	0.746
* p-value adjusted for binocular correlation influence by generalized estimating equation
† Individually included eyes with glaucoma-related adverse events, posterior synechiae, VAO, and any combination of these three postoperative complications.
VAO, Visual axis opacification.

The present study investigated the postoperative complications and axial length growth after bilateral congenital cataract surgery on microphthalmic eyes, and compared these with normally developed ones. The results showed that compared with infants without microphthalmos, infants with contemporary microphthalmos had a higher incidence of glaucoma-related adverse events and a slower AL growth rate, although 12 eyes in the microphthalmos group had grown to normal AL. However, both groups showed considerable improvements in visual acuity.

Glaucoma-related adverse events are vision-threatening complications in patients with congenital cataracts during the postoperative period due to optic nerve damage if not handled promptly and properly. In previous studies, the incidence of glaucoma after pediatric cataract surgery has been reported to vary from 3–41%.^{19, 20} A few studies have reported the incidence of glaucoma in children with congenital cataracts and microphthalmos (Table 9). Vasavada et al.²¹ observed that the prevalence of aphakic glaucoma after cataract surgery was 30.9% (13 of 42 eyes), while Prasad et al.²² reported a prevalence of 13.5% (5 of 37 eyes). In our study, the incidence of glaucoma-related adverse events was 16.7% in 42 microphthalmic eyes of 21 infants. This discrepancy might reflect differences in the follow-up duration, definition employed, surgeons, and study populations among studies. Postoperative glaucoma was classified into two types based on its bimodal onset^{20, 23}: early-onset closure-angle type and late-onset open-angle type. In a study by Kim et al.,²⁴ all patients with glaucoma had late-onset open-angle glaucoma. In our study, two of seven eyes developed postoperative early-onset closure-angle glaucoma, two eyes had late-onset open-angle glaucoma and the other three cases were diagnosed as glaucoma suspects based on the standard of diagnosis mentioned in the postoperative complications subheading of the methods section. The crowded anterior segment of microphthalmos, inflammatory reaction, along with iris stacking by using mydriatics might cause the early-onset closure-angle glaucoma. It is important to note that open-angle glaucoma was diagnosed in one of our patients (Pt 2, Table 2) who showed bilateral persistently high IOP with an open angle, four years after the operation, and was diagnosed as a glaucoma suspect before we found anatomical changes. This suggests that more late-onset open-angle glaucoma cases might be detected in our cohort in future follow-ups.

Table 9

Studies on infants with microphthalmos following cataract surgery
Study	Sample size (eye/children)	Definition of microphthalmos	Mean age at surgery (month)	Mean follow-up period (month)	Posterior synechiae	Visual axis opacification	Glaucoma	Definition of glaucoma	First-stage peripheral iridectomy	population
Vasavada et al. (2009)	42 eyes of 21 infants	an AL more than 2 SD smaller than the normal for that age group	4.0 ± 2.6 (0.5–10.1)	25.6 ± 11.3	35.7%	16.7%	30.9%	NA	Not reported	Indian
Praveen et al. (2015)	72 eys of 36 children	an AL that was 2 SDs smaller than what is normally expected at that age	4.8 ± 6.2 (0.5–15.0)	45.80 ± 2.90	27.8%	11.1%	30.6%	IOP was greater than or equal to 25 mm Hg on more than one occasion.	Not reported	Indian
Prasad et al. (2015)	37 eyes of 20 infants	AL of the globe is 16.50 mm or less	3.78 ± 2.25 (0.5–9.0)	18 ± 5.12	13.5%	10.8%	13.5%	NA	All infants	Not reported
Kim et al. (2019)	38 eyes of 19 children	a total AL at least 2 SDs below the mean for age	3.2 ± 1.7 (0.7–6.8)	93.48 ± 9.04	Not reported	Not reported	29.0%	IOP was ≥ 26 mm Hg on at least two consecutive visits or clinician’s decision for surgical intervention or permanent medical glaucoma therapy.	Not reported	Korean
The present study	42 eyes of 21 infants	a total AL at least 2 SDs below the mean for age	4.09 ± 1.87 (1.7-8.0)	34.96 ± 12.65 (16.0-58.3)	21.4%	14.3%	16.7%	See Methods section	Part of infants	Chinese
AL, axial length; SD, standard deviation.

Previous studies revealed potential risk factors for congenital cataract patients after cataract removal. In a 5-year follow-up study enrolled 686 eyes, Wang et al.¹⁰ reported that microcornea, FHCC and initial anterior vitrectomy were risk factors for glaucoma. The Pediatric Eye Disease Investigator Group²⁵ reported a higher risk for glaucoma-related adverse events was associated with age at surgery less than 3 months, abnormal anterior segment, intraoperative complications at time of lensectomy, and bilaterality, among 443 aphakic eyes. Although different risk factors mentioned, the abnormality of eye structure has been quite obvious. The effect of microphthalmos on the risk of developing glaucoma in patients with congenital cataracts is well established.^{16, 26} For example, Belitsky et al.¹¹ reported that microphthalmos was a significant risk factor for developing glaucoma. Some studies have further investigated the risk factors for postoperative glaucoma in patients with congenital cataracts and microphthalmos and reported that surgery at an early age is a risk factor in both normal and microphthalmic eyes of infants.^{16, 21–23, 27–29} Kim et al.²⁴ reported that patients with shorter ALs have a higher risk of developing glaucoma. However, our results showed that earlier surgical age and shorter AL were not associated with a higher incidence of glaucoma, which is inconsistent with the findings of previous studies. This could have been because (1) the age at surgery in our study was quite centralized; (2) a few patients had glaucoma; and (3) the follow-up period of this study was relatively limited, which is insufficient for some factors to show their influence. Besides, our study found that smaller dilated pupil size during surgery was nor a risk factor, though some considered its probable association with glaucoma after congenital cataract surgery. We supposed that the abnormality of eye structure might be the leading reason for higher postoperative glaucoma incidence in microphthalmos, and in such a cohort it might be hard to find other independent risk factors. Thus, we believe that an extended follow-up period would be valuable for evaluating the long-term incidence of glaucoma, particularly in microphthalmic eyes, and exploring the related risk factors.

In addition, in the study by Prasad et al.,²² all infants with microphthalmos underwent peripheral iridectomy during first-stage cataract surgery, following a 13.5% incidence of glaucoma. The mechanism of early-onset glaucoma may be related to genetic predisposing factors,^{28, 30–32} along with angle closure caused by a pupillary block or inflammatory peripheral anterior synechiae.^33–35 In this study, peripheral iridectomy was performed in two microphthalmic eyes at the primary lens removal procedure, considering the HCD and anterior chamber conditions and risk evaluation; none of the two eyes developed glaucoma. After excluding cases that combined peripheral iridectomy with cataract surgery, the incidence of glaucoma-related adverse events was 17.5% in 40 microphthalmic eyes of 20 infants. Two eyes that did not undergo peripheral iridectomy at the first stage developed angle-closure glaucoma and underwent peripheral iridectomy at the secondary IOL implantation. We believe that combining peripheral iridectomy with cataract surgery would prevent postoperative glaucoma-related adverse events, highlighting the importance of measuring HCD and careful assessment. This may also suggest that confounding risk factors affect the development of early-onset glaucoma.

A high incidence of inflammatory responses obstructs early visual rehabilitation after pediatric cataract surgery and may cause complex chain reactions. Increased vascular permeability in pediatric patients can easily cause fibrinoid inflammation,³⁶ causing the iris to adhere to the lens capsule membrane, known as posterior synechiae. Severe inflammatory reactions can produce excessive fibrin exudation, forming fibrinous membranes.³⁶ When the membrane fully covers the pupil area or the posterior synechiae block the fully circumferential pupil, secondary glaucoma associated with pupillary occlusion ensues. The fibrous membrane also contributes to the formation of VAO. In addition, due to the drastic proliferation and migration of lens epithelial cells, clouding of the visual axis area forms in the middle and late postoperative stages.¹⁸ However, adequate anterior vitrectomy could reduce this possibility.

Posterior synechiae were the most frequently observed complication in our study, occurring in 21.4% of 42 microphthalmic eyes and 19.0% of normally developed eyes. In the study by Praveen et al.,³⁷ the incidence of posterior synechiae was 27.8%, whereas Vasavada et al.²¹ reported a higher incidence of 35.7%. In the present study, one eye in the microphthalmos group developed glaucoma due to pupillary atresia caused by posterior synechiae. Our team routinely prescribed topical steroids and mydriatic immediately after surgery to prevent posterior synechiae and pupillary occlusion. However, in infants with microcorneas, excessive mydriasis might cause goniosynechia and even angle closing of the anterior chamber, which implies the need for a close follow-up and monitoring by the doctors. Moreover, infants with immature or incompletely mature dilator pupillary muscles cannot fully respond to medication, and some develop posterior synechiae due to stimulation by chronic inflammation.

Visual axis opacification is the most common complication of pediatric cataract surgery, especially in infants,³⁸ with an incidence varying from 9.2–37.9%.^39–44 In the present study, the incidence of VAO was 14.3% in the microphthalmos group, which was similar to that in previous studies on microphthalmos, ranging from 5.2–16.7%.^{21, 37, 45, 46} The incidence of postoperative VAO may also vary according to differences in the individual development of pupil and surgical experience and technique among surgeons.

Early cataract surgery is essential for preventing amblyopia and improving visual function in infants with cataracts. The visual acuity results of the microphthalmos group in our study were satisfactory and similar to those of the comparison group. Previous studies reported similar results.^{21, 22, 47} Despite the increased risk of complications that threaten visual function after surgery, we believe that infants with congenital cataracts and microphthalmos will still benefit from early surgical intervention based on a timely and accurate postoperative optical correction.

In a previous study by our team,⁴⁸ we established an AL estimate formula for children aged ≤ 2 years with congenital cataracts who underwent cataract surgery; however, for infants with microphthalmos, the formula might be more complicated. This study found that AL growth was slower in the microphthalmos group than in the comparison group after excluding seven eyes with glaucoma-related adverse events. Our study showed results divergent from those of previous studies. In the study of Sun et al.,⁴⁹ the growth rate was higher in the microphthalmos group, while there was a significant difference in age at surgery between the microphthalmos group and the comparison group (3.2 ± 1.3 vs. 5.9 ± 3.0 months, p < 0.001), which could affect results. Seven et al.⁵⁰ found a significantly negative correlation between age at surgery and changes in AL and the monthly growth rate. Therefore, our study, with no significant difference in age at surgery between the two groups (4.09 ± 1.87 vs. 4.84 ± 2.08 months, p = 0.068), might be more convincing.

At the last follow-up, 12 eyes (34.3% of 35 eyes) in the microphthalmos group had progressed to age-matched normal AL. AL is related to hereditary factors,⁵¹ physical development,^{45, 52} nutrition, and other environmental factors. Various factors can affect axial elongation. We hypothesized that some patients with microphthalmos might suffer more from form deprivation caused by their cataracts, which probably inhibit eyeball development rather than genetic defects. Previous studies built postoperative AL prediction models for children undergoing congenital cataract surgery, based on baseline AL, age at surgery and IOL status.^{48, 53} However, the postoperative AL of our microphthalmos patients deviate from these models. One hand, patients with microphthalmos occupy a relatively small proportion in congenital cataracts, leading large error in prediction. The other hand, the mechanism of axial elongation in microphthalmos could be more complex, and future AL growth in microphthalmic eyes remains difficult to predict, which requires a larger sample size and a longer follow-up period for further investigation.

The results of this study should be viewed in light of these limitations. First, it was a retrospective study with a small sample size. Second, the follow-up period was relatively short; a longer follow-up period may reveal the development of glaucoma, especially the late-onset open-angle type, in some eyes. Further prospective studies with larger sample sizes and longer follow-up periods are warranted.

In conclusion, early surgical intervention improves visual function in infants with congenital cataracts and microphthalmos. And microphthalmic eyes had a higher incidence of postoperative glaucoma than normally developed eyes. After cataract removal, the AL growth of microphthalmic eyes is slower than that of normally developed eyes, providing an important basis for surgeons to choose the timing of secondary IOL implantation.

Acknowledgements

Yiling Jiang and Yinying Zhao contributed equally as co-first authors.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was supported by the "Pioneer" and "Leading Goose" R&D Program of Zhejiang (Grant No. 2022C03070), the Science and Technology Program of Wenzhou City (Grant No. Y20211009) and Provincial Construction Project of Zhejiang Province (Grant No. WKJ-ZJ-2135).

Authors' contributions

Design of the study (Y.E.Z., Y.Y.Z., Y.L.J., J.N., D.D.W.); conduct of the study (Y.E.Z., Y.L.J., Y.Y.Z., J.N., D.D.W., F.M.Y.); collection of data (Y.L.J., J.N., F.M.Y.); interpretation of the data (Y.L.J., H.L.L, J.N., F.M.Y.); preparation of the manuscript (Y.L.J, Y.E.Z., Y.Y.Z.); and final approval of the manuscript (Y.E.Z.). All authors read and approved the final manuscript.

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Postoperative Complications and Axial Length Growth after Bilateral Congenital Cataract Surgery: Eyes with Microphthalmos Compared to a Comparison Group

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Abstract

Figures

1 Introduction

2 Methods

2.1 Patients selection

2.2 Surgical technique

2.3 Primary outcome measures

2.3.1 Ocular biological parameters and demographic features

2.3.2 Visual function assessment

2.3.3 Postoperative complications

2.4 Statistical analysis

3 Results

3.1 Demographic features and ocular characteristics

3.2 Postoperative complications and relative risk factors

3.3 The axial length growth

3.4 The visual function

3.5 Microcornea eyes in the microphthalmos group

4 Discussion

5 Conclusions

Declarations

References

Additional Declarations

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