Study design
This study is a retrospective cohort study that was performed at the Eye Center of Xiangya Hospital, Central South University, Changsha, China. Patients who underwent cataract surgery in our department were consecutively included from October 2018 to October 2020. Inclusion criteria were as follows: 1) total corneal astigmatism ranging between 0.5 D and 2.0 D preoperatively; 2) implantation of ZMB00 multifocal IOLs (Abbott Medical Optics, Inc., California,USA); and 3) a single CCI or OCCI was made on the steepest meridian. Exclusion criteria were as follows: 1) corneal astigmatism greater than 2.0 D or irregular astigmatism; 2) presence of eye disease other than cataract; 3) a history of eye trauma and/or previous ocular surgery; and 4) intra-operative complications.
Eighty eyes of 80 patients, ranging in age from 37 to 81 years, were included. One eye per one patient was used in this study. If both eyes that underwent cataract surgery were eligible for this study, the first surgical eye was selected.
Corneal astigmatism was measured with Scheimpflug topography (Pentacam; Oculus, Inc, Wetzlar, Germany), and patients were divided into a CCI group and an OCCI group by pre-operative total corneal astigmatism. Patients with 0.5–1.2D pre-operative corneal astigmatism were included in the CCI group and received a single CCI on the steep meridian, and patients with 1.3–2.0 D were included in the OCCI group and received OCCI on the steep meridian. A total of 41 patients were included in the CCI group and 39 patients were included in the OCCI group. Both groups consisted of superior, temporal, and oblique subgroups on the basis of the steepest corneal meridian. The orientation of corneal astigmatism was regarded as againstthe-rule astigmatism(ATR) in the case of the steepest keratometric readings being between 0–30 and 150–180 degrees, oblique astigmatism was between 30–60 and 120–150 degrees, and with-the-rule astigmatism(WTR) was 60–120 degrees. The pre-operative clinical data of patients in the CCI and OCCI groups is described in Table 1.
Table 1
Pre-operative baseline clinical data of patients.
|
CCI group
|
OCCI group
|
P
|
No.
|
41
|
39
|
/
|
Age (year)
|
64.9 ± 9.1
|
58.9 ± 12.4
|
0.09
|
Female/Male
|
21/20
|
20/19
|
0.78
|
Right eye/Left eye
|
19/22
|
21/18
|
0.57
|
Nuclear opalescence grade
|
2–4
|
2–4
|
/
|
Mean corneal astigmatism(D)
|
0.98 ± 0.22
|
1.63 ± 0.27
|
<0.001
|
Mean corneal power(D)
|
43.87 ± 1.76
|
43.84 ± 1.70
|
0.97
|
The orientation of corneal astigmatism
|
WTR
|
17
|
15
|
0.78
|
ATR
|
19
|
19
|
oblique
|
5
|
5
|
Corneal Total HOAs
|
0.092 ± 0.014
|
0.140 ± 0.018
|
<0.001
|
Ocular Total HOAs
|
0.232 ± 0.042
|
0.286 ± 0.023
|
0.62
|
UDVA(logMAR)
|
0.98 ± 0.04
|
1.06 ± 0.08
|
0.53
|
VF-14score
|
65.12 ± 1.78
|
67.23 ± 3.14
|
0.98
|
WTR: with-the-rule; ATR:against-the-rule; UDVA:uncorrected distance visual acuity |
The study was approved by the Xiangya Hospital ethics committee and was performed in accordance with the tenets of the Declaration of Helsinki. All patients signed informed consent forms before cataract surgery, and data were collected anonymously.
Intraocular lens
The TECNIS ZMB00 is a UV-blocking, hydrophobic, acrylic, single-piece IOL. It has a C-loop haptic with near power added (+ 4.0 D) at the IOL optic plane. The IOL is designed as biconvex and consists of a wavefront-designed, anterior aspheric surface (negative spherical aberration − 0.27 µm) and posterior diffractive surface with 22 diffractive rings. The IOL power was calculated by the same technician using an IOL Master 500 optical biometer (Carl Zeiss Meditec AG, Jena, Germany) using the Haigis formula. Parameters included axial length, corneal power and anterior chamber depth.
Surgical Technique
All surgeries and corneal meridian markings were performed by the same surgeon (J.J). The steep corneal meridian was marked prior to surgery using a slit lamp. Briefly, the patient’s head was positioned on the slit lamp and the patient was asked to keep the contralateral eye open and to look forward. The slit beam was narrowed to a thin slit, centered on the pupil and aligned with the 0°–180° marks of the calibrator. Then, using a sterile 30-gauge needle, two small superficial incisions were made at the periphery of the cornea where the slit beam cut the limbus at the 0°–180° position. Care was taken to keep the slit beam on the center of the pupil for alignment. Incisions were fixated with a sterile marker pen for easier intraoperative recognition. Finally, the correct position markings were verified at the slit lamp (Fig. 1).
Surgery was performed using topical anesthesia in both groups. After the Mendez-style corneal marking ring was aligned to the two preoperative markings, dots were made using a blue pen on the planned meridian (Fig. 1). A self-sealing 3.0 mm CCI was made 1 mm anterior to the limbus on a steep meridian using a 3.0 mm keratome (Alcon Laboratories, Inc. Fort Worth, USA). There is a 2 mm marking line on the surface of the keratome so that we can ensure that the tunnel length is 2 mm. The standard phacoemulsification procedure was performed via 2 incisions. Routine phacoemulsification was performed using a standard ultrasound technique (Centurion, Alcon Laboratories, Inc. Fort Worth, USA), followed by insertion of a foldable multifocal IOL (ZMB00). The OCCI was made on the opposite steep meridian 1 mm anterior to the limbus using the same keratome prior to removal of viscoelastic material; the length of corneal tunnel was also 2 mm. Only the phacoemulsification incision was hydrated at the end of surgery. All patients received routine postoperative topical steroids for 4 weeks and antibiotic eye drops for 2 weeks.
Main Outcome Measures
Uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) were evaluated by an optometrist; the patients and optometrists were masked during vision testing. The decimal visual acuity was then converted to a logMAR scale for statistical analysis. Corneal astigmatism was assessed using Scheimpflug topography (Pentacam ; Oculus, Inc, Wetzlar, Germany), and the root mean square (RMS) of ocular and corneal HOAs, including total HOAs, coma (Z3 − 1 and Z3 1), spherical aberration (Z4 0), secondary astigmatism (Z4 − 2 and Z4 2), and trefoil (Z3 − 3 and Z3 3), were assessed with the Zernike coefficient (iTrace, Tracey Technologies Inc., Houston, USA) in a 3.0 mm diameter central area. Astigmatic change was calculated as the difference between mean preoperative and postoperative topographic readings. Surgically induced astigmatism (SIA) was evaluated using the vector analysis on Dr. Warren Hill’s website (https:// sia-calculator.com/).To determine whether different location of CCI and OCCI can induce different corneal astigmatism, we compared SIA, corneal astigmatic change between patients with WTR and ATR astigmatism. Five patients with oblique astigmatism in CCI or OCCI group were excluded from this comparison.
The Visual Function scale-14 (VF-14) was used to evaluate postoperative visual quality. The scale included 4 items: subjective vision, visual adaptation, peripheral vision and stereoscopic vision12. Each item was graded from 1 to 5 points, and a higher score indicated higher visual satisfaction. The final score was the average value times 20; higher scores indicated better postoperative life and visual quality.
UDVA, UNVA, total corneal astigmatism and HOAs were recorded before surgery. UDVA and UNVA were observed at 1, 4, and 12 weeks post-surgery. The HOAs were determined 12-weeks post-surgery. The VF-14 questionnaire, glare, halos, and the need for spectacles were recorded at 12 weeks post-surgery.
Statistical Analysis
Statistical analysis was performed using SPSS software (version 21.0; SPSS, Inc.). Categorical variables were compared with use of the Fisher’s exact test. A Wilcoxon Signed Ranks test was used to analyze preoperative and postoperative data. A Mann–Whitney test was used to analyze the data between the two groups. A p value less than 0.05 was considered statistically significant.