Effectiveness of prismatic combination treatment on children with amblyopia combined with esotropia

doi:10.21203/rs.3.rs-3649798/v1

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Effectiveness of prismatic combination treatment on children with amblyopia combined with esotropia

https://doi.org/10.21203/rs.3.rs-3649798/v1

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Purpose

Prism has been used as a non-surgical treatment for certain types of strabismus; however, its role as the primary intervention for amblyopia combined with esotropia has been rarely studied. The objective of this study was to compare the effectiveness of prismatic correction with traditional occlusion therapy in treating amblyopia combined with esotropia.

Methods

This retrospective case-control study included children aged 3 to 16 years with amblyopia combined with esotropia. After refractive correction, the patients were divided into two groups. The control group received traditional occlusion therapy combined with binocular treatment, while the prism group received full correct prisms combined with binocular treatment. Clinical characteristics, visual acuity, binocular functions, and the angle of esodeviation were assessed at each follow-up examination. The treatment outcomes after 12 months were evaluated to determine the more effective protocol.

Results

At baseline, there were no significant differences in age, gender ratio, best-corrected visual acuity (BCVA) of the amblyopic eye, deviation amount (△), and binocular vision function between the two groups (all P > 0.05). After treatment, both groups showed improvement in amblyopic eye visual acuity. The difference in visual acuity improvement between the two groups was not statistically significant at 6 months (0.18±0.17 vs 0.14±0.11, P > 0.05), but it was statistically significant at 12 months (0.35±0.20 vs 0.25±0.18, P < 0.05). The prism group demonstrated a significant improvement in binocular vision function, whereas there was no significant change in the control group at 6 months or 12 months after treatment. The deviation amount (△) remained stable in both groups, with no significant difference between the two groups after treatment.

Conclusion

Prismatic treatment combined with binocular treatment was more effective in improving amblyopic eye visual acuity and binocular vision compared to traditional occlusion therapy combined with binocular treatment in children with amblyopia combined with esotropia. Prismatic correction could be considered as the first-line treatment for amblyopia combined with esotropia.

Health sciences/Diseases

Health sciences/Medical research

Amblyopia is a condition characterized by reduced vision resulting from insufficient visual experience during the early years of life. Strabismus is the primary factor associated with amblyopia, particularly during the first three years ^[1]. Strabismic amblyopia is known to cause more severe deficits in monocular visual acuity and binocular acuity compared to anisometropic amblyopia ^{[2, 3]}.

The conventional nonsurgical treatment for amblyopia combined with esotropia involves optical correction followed by occlusion or penalization of the dominant eye. While this treatment approach achieves good outcomes in visual acuity, it often leads to poor results in binocular vision for individuals with amblyopia ^[4]. Moreover, in cases of infantile esotropia, even with early optical correction and surgery, less than 0.5% of patients in prospective cohorts achieved normal stereoacuity by the age of 5, and over 60% had no stereoacuity ^{[5, 6]}. However, having stereopsis is associated with a reduced risk of recurrent esotropia or consecutive exotropia requiring surgery in infants with esotropia ^[7]. Therefore, there is a need for new approaches to improve visual acuity and binocular vision in cases of amblyopia combined with esotropia.

Fresnel press-on prism (FPP) was introduced in the 1970s as a method to provide prismatic correction for patients with visual impairments ^[8-10]. Prismatic treatment has also been used as a non-surgical approach for diplopia and divergence insufficiency esotropia. Some previous reports have demonstrated that prismatic correction can be beneficial for improving amblyopia and binocular vision in cases of partially accommodative esotropia ^[11-14].

On the other hand, several studies have documented the effectiveness of binocular treatment in improving stereopsis, regardless of the type of amblyopia (anisometropic or strabismic) ^[15-22]. There is strong evidence supporting the use of binocular treatments to enhance visual acuity and improve binocular function in individuals with amblyopia, making it a viable additional treatment option ^{[16, 23]}.

Clinicians have multiple treatment options for managing amblyopia combined with esotropia. However, to the best of our knowledge, no previous studies have compared the effectiveness of different combination treatments, specifically binocular treatment combined with occlusion therapy versus prism treatment. Therefore, the purpose of this study is to assess the efficacy of prismatic correction compared to occlusion therapy in cases of amblyopia combined with esotropia.

Subjects

This retrospective study included 74 patients diagnosed with amblyopia combined with strabismus between October 2016 and December 2020 at the Department of Ophthalmology of Second Xiangya Hospital. The study adhered to the principles outlined in the Declaration of Helsinki and received approval from the Ethics Committee of Second Xiangya Hospital (Approval Number: LYG2023008). Written informed consent was obtained from all participants and their guardians for the use of clinical records in the study.

The inclusion criteria were as follows: (1) children aged 3 to 16 years; (2) children with corrected visual acuity of the better eye ≥ 0.5 and amblyopic eye vision ≥ 0.02; (3) children with esotropia degree ≥ 12 ^Δ.

The exclusion criteria were as follows: (1) children with other ophthalmic diseases, such as keratitis and glaucoma; (2) children who did not comply with the treatment or withdrew from the study; (3) children with a history of serious diseases, such as heart, liver, kidney, or mental diseases; (4) children who had abnormal eye movements, inability to gaze independently, or exhibited symptoms of vertical squint; (5) complete accommodative esotropia.

Ophthalmological examination

All children with amblyopia and esotropia underwent ophthalmologic and orthoptic examinations to evaluate their binocular visual functions. The deviation of strabismus was measured using the cover test with prism.

The collected data included sex, age, visual acuity, time from onset to treatment, cycloplegic refractive error, Worth 4-dot test score, angle of deviation, and measurement of stereopsis using a random-dot stereotest. Visual acuity was measured by the same optometrist for uncorrected and best-corrected conditions.

The angle of strabismus was measured using the alternate prism cover test with full refractive correction. Binocular functions were assessed using the Worth 4-dot test (for simultaneous vision) and the random-dot stereotest (for stereopsis vision), which were graded into four levels (Table 1). Stereopsis was categorized into two levels: ≤800 arcseconds and > 800 arcseconds. In the Worth 4-dot test, a positive response was considered when all four lights were visible and fused.

Treatment methods

All patients underwent a comprehensive ophthalmological examination. Initially, 1% atropine eye cream was administered once daily. After seven days, retinoscopy and optometry were performed, and completely corrected glasses were prescribed for esotropia and refractive errors. Complete accommodative esotropia was ruled out after wearing glasses for 6 months. The angle of esodeviation was measured using the prism alternate cover test.

After refractive correction, the patients were divided into two groups based on whether they agreed to undergo press-on prism treatment for at least 1 year, as accepted by the participants and their guardians. In the control group, traditional occlusion treatment was provided, while in the prism group, full correct base-out press-on prisms were prescribed for all patients and applied only to the bottom of the spectacle lens, with the prism being pressed onto the refractive lens of the dominant eye. Only a few patients required decrement occlusion therapy. Treatment protocols are listed in Table 2.

Both groups received binocular treatment using the dichoptic training system, 1–2 times a day for 20 minutes each session.

Follow-up examinations were conducted every 3 months until 1 year after prescribing the prism glasses. The angle of deviation, stereoacuity, and best-corrected visual acuity (BCVA) were assessed during follow-up.

Detection indexes

During the treatment, both groups of patients underwent re-examination every 3 months for routine ophthalmic examinations, including vision, strabismus, prism examination, and binocular visual functions. The best-corrected visual acuity (BCVA), binocular visual functions, and deviation were evaluated in both groups.

Table 1

Grade of binocular vision
Grade	binocular vision test
0	Worth 4 Dot test (-)
1	Worth 4 Dot test (+)
2	radom-dot stereotest > 800
3	radom-dot stereotest ≤ 800

Table 2

Treatment protocols(12month)
group	control group	prism group
Treatment protocols	traditional occlusion therapy+ Dichoptic training	Prism + decrement occlusion therapy +Dichoptic training
BCVA of amblyopic eye < 0.2	full-time patching	6h/day patching
BCVA of amblyopic eye ≥ 0.2	6h/day	No patching

Statistical analysis

The data were analyzed using Statistical Program for Social Sciences (SPSS) version 19.0 software (SPSS, Inc., Chicago, IL, USA). A two-tailed t-test was employed to determine statistical significance for visual acuity improvement and clinical characteristics before treatment, such as age, best-corrected visual acuity (BCVA) of the amblyopic eye, and deviation amount between the groups. The data were presented as means ± standard deviation (SD). The male/female (M/F) ratio and stereoacuity were compared between the two groups using the chi-square test. Differences were considered statistically significant when P < 0.05. Pre-treatment data for the two groups are listed in Table 3

Table 3

Clinical characteristics at the beginning of the patients in the study
Items	Prism group	Control group	P value
Total (N)	36	38
Mean age (years)	5.25 ± 2.43	5.36 ± 1.79	0.811
M/F ratio	16/20	25/13	0.065
BCVA of amblyopic eye	0.35 ± 0.20	0.32 ± 0.18	0.382
Deviation amount (△)	25.44 ± 11.68	23.68 ± 11.66	0.519

General information

Table 3 displays general information, including the mean age, M/F ratio, BCVA of the amblyopic eye, and deviation amount (△) for both groups. The results indicated no significant differences in age, M/F ratio, BCVA of the amblyopic eye, or deviation amount (△) between the two groups (all P > 0.05), suggesting no bias in the case selection between the groups.

Treatment effect of amblyopia

The improvement in visual acuity of the amblyopic eye was analyzed between the two groups. As shown in Table 4, the prism group demonstrated an average improvement of 1.8 lines at 6 months and 3.5 lines at 12 months (n = 36), while the control group showed an average improvement of 1.4 lines at 6 months and 2.5 lines at 12 months (n = 38). The difference in visual acuity improvement between the two groups was not statistically significant at 6 months (0.18 ± 0.17 vs 0.14 ± 0.11, P = 0.194), but it was statistically significant at 12 months (0.35 ± 0.20 vs 0.25 ± 0.18, P = 0.025). (Fig. 1)

Table 4

BCVA improvement (logMAR) of patients in two groups
Items	Prism group	control group	P value
Total (N)	36	38
6monBCVA improvement	0.18 ± 0.17	0.14 ± 0.11	0.194
12monBCVA improvement	0.35 ± 0.20	0.25 ± 0.18	0.025

* P < 0.05

Binocular visual function reconstruction

Post-treatment, the binocular visual functions, including simultaneous vision and stereoscopic vision, were evaluated in both groups, as presented in Table 5. There was no difference in binocular visual function between the two groups before treatment (P = 0.65). However, significant differences in binocular visual function were observed between the two groups at 6 months (P = 0.02) and 12 months (P = 0.00) after treatment. Binocular visual function significantly improved in the prism group (P = 0.00), (Fig. 2) whereas there was no significant improvement in the control group. These results indicate that prismatic treatment leads to significant binocular visual function reconstruction while reducing the duration of occlusion compared to traditional occlusion therapy.

Table 5

Treatment effect on binocular visual function
Groups	Prism group (N = 36)				Control group (N = 38)				P value
Groups	Grade0	Grade1	Grade2	Grade3	Grade0	Grade1	Grade2	Grade3	P value
Pre-treatment	18 (50.0%)	18 (50.0%)	0 (0.0%)	0 (0.0%)	21 (55.3%)	17 (44.7%)	0 (0.0%)	0 (0.0%)	0.65
Post-treatment 6month	6 (16.7%)	23 (63.8%)	1 (2.8%)	6 (16.7%)	15 (39.5%)	22 (57.9%)	1 (2.6%)	0 (0.0%)	0.02*
Post-treatment 12month	2 (5.6%)	21 (58.3%)	4 (11.1%)	9 (25.0%)	17 (44.7%)	20 (52.6%)	0 (0.0%)	1 (2.6%)	0.00**
Prism group: Pre-treatment vs Post-treatment 6 month vs Post-treatment 12 month P = 0.00
control group: Pre-treatment vs Post-treatment 6 month vs Post-treatment 12 month P = 0.458

* P < 0.05

** P < 0.01

Table 6

The angle of deviation (△) pre-treatment and post-treatment in two groups
	Pre-treatment (△)	Post-treatment 6month(△)	Post-treatment 12month(△)	F	P value
Prism group (N = 36 )	25.44 ± 11.68	25.92 ± 11.48	26.25 ± 12.68	0.041	0.960
control group (N = 38 )	20.13 ± 10.43	20.26 ± 10.26	21.79 ± 10.05	0.307	0.736

The treatment duration and follow-up visits for both groups were 12 months. From Table 6, the analysis revealed that the strabismus deviation in both groups did not significantly change after treatment compared to before treatment, indicating stabilization of squint in esotropia patients after treatment.

The development of binocular function commences at 6 weeks and reaches completion by 6 months. Strabismus during the early years is likely to impede the development of binocular vision. Anomalies in binocular vision can result in confusion, diplopia, which leads to suppression, eccentric fixation, anomalous retinal correspondence, and amblyopia. Strabismus, as a significant factor associated with amblyopia, has often been overlooked in traditional amblyopia treatment.

This study aimed to compare the long-term effects of prismatic combination treatment and traditional occlusion combination treatment for patients with amblyopia combined with esotropia.

Traditional occlusion therapy is an effective treatment for promoting the restoration of visual acuity in amblyopia. Studies have shown different outcomes of occlusion therapy, with patching treatment improving visual acuity by 0.19 to 0.37 logMAR (2–4 lines) within 6 months ^[17,24]. In our study, amblyopic eye visual acuity improved in both treatment groups. There was a 0.14 logMAR improvement with occlusion combination treatment at 6 months. The poorer outcomes in our study may be attributed to the fact that all cases of amblyopia were combined with esotropia. Strabismic amblyopia is associated with disproportionately larger deficits in optotype and vernier acuity compared to anisometropic amblyopia ^[4]. While occlusion therapy can reduce interocular suppression during patching, it cannot address interocular suppression arising from the deviated eyes in strabismus when patching is not applied. Importantly, we found that prismatic treatment was more effective than traditional occlusion therapy in improving amblyopic eye visual acuity at 12 months (0.35 vs 0.25 logMAR). This finding suggests that prismatic treatment is more effective in reducing interocular suppression caused by binocular visual axis deviation and visual field overlap. However, it is worth noting that due to the reflection of the prism face, the refraction of the prism base, and the diffraction effect of the groove, the visual acuity of the eyes wearing prisms decreases with increasing prism power ^[25]. By placing the prism on the refractive lens of the dominant eye, it can also inhibit the dominance of the fellow eye and act as a covering membrane. A previous study demonstrated that the impact of pressing prisms on reducing normal vision is more pronounced than on amblyopia ^[26]. Therefore, in patients with strabismus, prisms are applied to the healthy eye or the eye with better vision to reduce the visual imbalance between the two eyes and stimulate the fovea of the amblyopic eye. Consequently, prismatic treatment and occlusion therapy yield similar improvements in visual acuity at 6 months post-treatment, but prismatic treatment exhibits better outcomes at 12 months.

In clinical practice, improving visual acuity is the primary goal of amblyopia treatment, and once achieved, treatment is typically terminated. However, nearly half of individuals whose visual acuity deficit resolves still experience persisting binocular deficits ^[4]. Furthermore, strabismic amblyopes, whether with or without anisometropia, suffer from impaired stereopsis, regardless of the visual acuity of the weaker eye ^[27]. Therefore, in addition to attaining normal visual acuity, restoring binocularity is also an important treatment objective. Preliminary evidence suggests that binocular treatments may enhance stereoacuity and visual acuity in individuals with amblyopia ^[28–30].

After 12 months of dichoptic videogame play training, there was no observed effect on binocular vision function in the traditional patching group, while the prism group showed effective improvement in binocular vision. The traditional patching with binocular training seemed to yield worse results compared to previous research. One explanation for the poorer outcomes was the high percentage of esotropia (100%) and low degree of binocular vision function in this study. More than half of the children in our study (Worth 4-dot test) did not have simultaneous vision, and none of them had stereopsis vision prior to treatment. Strong evidence suggests that patients with strabismic amblyopia have a much lower probability of improvement with binocular training compared to anisometropic amblyopia ^{[27, 31–33]}. Another reason was that patching itself may lead to reduced binocular vision and stereopsis. Furthermore, during the period without patching and binocular training, the eyes were still unable to work together due to the visual axis deviation in esotropia. Therefore, the prism group showed much better outcomes. The results demonstrated that without prism, binocular training had a significantly lower effect on the recovery of binocular vision in amblyopia combined with esotropia. This finding challenges the prevailing view and suggests that dichoptic training improves stereopsis in all types of amblyopia. However, another study comparing the efficacy of binocular vision training (BVT) and prism in children with esotropia combined with amblyopia found that prismatic treatment without binocular training can effectively promote the recovery of binocular vision ^[12]. These findings support the etiological hypothesis that restoring binocular single vision fusion is essential for binocular function.

In our study, after 12 months of prismatic treatment combined with binocular training, 94.4% of patients achieved simultaneous vision, and 47.1% of them obtained stereopsis vision. This outcome was much better than that of traditional occlusion combination treatment. The good response to prismatic treatment in this study supports the predominant theory that amblyopia arises when there is a mismatch between the images received by each eye. In other words, strabismus is the primary cause of amblyopia combined with esotropia. Pressing and pasting prisms are suitable correction methods for strabismus, as they can project the object image of gaze onto the fovea of the macula through object image displacement. Prismatic treatment resolves the visual problems caused by binocular visual axis deviation and visual field overlap, leading to the occurrence of single, binocular vision when the images formed on the retina from each eye contribute to a single image. This can also explain why binocular training showed no effect on the recovery of binocular vision in the traditional patching group in this study.

On the other hand, prisms have been used to reduce the amount of esodeviation and improve sensory status in partially accommodative esotropia (PAET) and acquired strabismus ^{[8, 13, 14, 34]}. However, the long-term effect of prisms in reducing the angle of esodeviation in amblyopia has not been evaluated. Therefore, in this study, we obtained the long-term results of prismatic correction in amblyopia combined with esotropia. The amount of esodeviation showed favorable stability in both groups after 12 months of treatment. Moreover, the strabismus deviation showed no significant difference between the two groups, regardless of pretreatment and post-treatment. Previous studies have reported success rates of 23.7%-38.9% (cases where prism glasses were eventually no longer needed) in esotropia of 25 prism diopters or less. The stability we found here in both groups seems inconsistent with those reported in previous studies, which may be due to the relatively small number of patients (9 cases in the prism group vs. 9 cases in the control group) with PAET of 25 prism diopters or less. Another reason for this result may be that those who weaned off prism within 6 months were excluded as complete accommodative esotropia. This finding may serve as evidence that the improvement of visual acuity promotes stability of strabismus deviation in esotropia combined with amblyopia.

There were some limitations to our study. First, due to the relatively small number of patients, we were unable to analyze changes in visual function based on the degree of strabismus deviation. Second, because younger children had poor compliance and understanding for fusion tests with the synoptophore, we had to exclude this index from the assessment of binocular visual function. Third, since dichoptic training might have a learning curve, and patient compliance could differ based on age, additional studies examining the correlations among age, follow-up period, and the total number of tests are needed.

In conclusion, the combined use of prismatic treatment and binocular training can more effectively promote the recovery of visual acuity and binocular visual function compared to traditional occlusion therapy and binocular training in children with amblyopia and esotropia. For patients with strabismus combined with amblyopia, if prismatic treatment is available in the early years, better visual stimulation and response may be achieved, improving the correspondence of the normal retina, eliminating inhibition, and promoting the recovery of binocular visual function. Additionally, the recovery of binocular visual function in children before surgery can improve the success rate of strabismus surgery ^[37]. Prismatic correction can be considered as the first-line treatment for amblyopia combined with esotropia. Furthermore, prismatic treatment and binocular treatment can be an optimal combined treatment for amblyopia combined with esotropia.

Data availability statement：

The datasets used during the current study available from the corresponding author on reasonable request.

Author contribution statement：

Xin Wei and man-yi Xiao wrote the main manuscript text and Yin Wu and Xin Qi prepared figures, Ye Hu collected date. All authors reviewed the manuscript.

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No competing interests reported.

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Effectiveness of prismatic combination treatment on children with amblyopia combined with esotropia

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