The study protocol was approved by Cairo University Research Ethics committee. The study and data collection conformed to all local laws and were compliant with the principles of the Declaration of Helsinki. A prospective interventional study was performed on patients with axial anisometropia during the period from January 2015 through December 2017. An informed consent was obtained from all patients.
Twenty patients with axial anisometropia caused by unilateral myopia > 5 D with > 4 D difference in the spherical equivalent between both eyes who were suitable candidates for refractive surgery; excimer laser ablation or implantable collamer lens implantation (ICL) were included in the study.
The diagnosis of axial anisometropia was confirmed if the difference in the axial length between both eyes was > 1mm and the difference in the mean keratometric readings of both eyes was < 1 D. Patients were included if the mean spherical equivalent in the less ametropic eye was <1 D and the mean cylindrical error in the less ametropic eye was < 2 D. Patients had to be been regularly wearing spectacles and/or contact lenses for the past 6 months. Patients with any manifest or intermittent deviation were excluded from the study.
Patients were considered a suitable candidate for refractive surgery if they were above 21 years and younger than 45 years, had a stable refraction over > 6 months, and have no other ocular or systemic diseases that might affect the visual outcome, including but not limited to ectatic corneal conditions, cataractous changes, or glaucoma. Patients were considered a suitable candidate for excimer laser ablation if the ectasia risk score is 2 points or less [11]. ICL implantation was used if the spherical equivalent was > 10 D and/or the ectasia risk score is > 2 points, and if the ACD was >= 3.2 mm.
Full ophthalmic history was taken from each patient, including history of previous ocular trauma or surgery, or history of ocular diseases. Each patient underwent full ophthalmic examination; including uncorrected (UCDVA) and corrected distance visual acuity testing (CDVA) using single crowded optotype, intraocular pressure measurement, anterior segment slit lamp examination, and a dilated fundus examination. In addition, cycloplegic refraction was done approximately 30 min after topical instillation of cyclopentolate 1% 3 times.
Axial length, and anterior chamber depth were measured using Sonomed 300A+ PacScan A Scan (Sonomed Escalon, NY, USA). Corneal topography was done using Pentacam (Pentacam HRTM, Oculus Optikgeräte GmbH, Wetzlar, Germany).
All patients had measurement of CDVA, and evaluation of fusion and stereoacuity using spectacles, and the using contact lenses. Spectacles were checked to ensure that they were in the correct spectacle plane; approximately 12-13 mm from the corneal vertex. Refraction was checked with the patient wearing contact lens to ensure that the residual refractive error with contact lens – if present – was < 0.5 D sphere and < 1.0 D cylinder in the more ametropic eye. Fusion was evaluated using Worth 4-dot test for distance. Stereoacuity was then evaluated using TNO test (Laméris Ootech BV, Ede, Netherlands). Finally, aniseikonia was evaluated using a custom software that projects 2 equal vertical red and blue bars on a computer monitor. The patient wore red-blue anaglyphic glasses on top of spectacles or contact lenses and was asked to adjust the size of the blue bar using a keyboard pad until the patient subjectively felt that the red and blue bars were equal in size. The red and blue bars were then oriented horizontally, and the procedure was repeated. The software automatically calculated the aniseikonia as difference in the image size in percentage [12].
Patients were then divided into 2 groups according to whether laser corneal surgery or implantable collamer lens implantation was performed.
In the LASIK group, the corneal flap was performed using Moria M2 microkeratome with 90 μm head (Moria, Antony, France). The stromal bed was then dried, and excimer laser ablation was applied using Schwind Amaris 750S (Schwind eye-tech-solutions, Kleinostheim, Germany). The optical zone of the treatment was set at 6.50 mm. The system automatically calculated the transition zone according to the amount of correction needed and to the selected optical zone. For all patients, the programmed treatment consisted of the manifest refraction. All values were entered without nomogram adjustment. Proper alignment of the eye was ensured before and during the ablation with the built-in eye tracker that automatically compensated for any cyclotorsion. Fixation light was used for fixation throughout the ablation. After the ablation was completed, the interface with irrigated with balanced salt solution, any debris was removed, and the flap was repositioned. Postoperative treatment included a combination of topical antibiotic and steroid drops (Tobradex, Novartis, Basel, Switzerland) 4 times daily for 2 weeks, and artificial tears (Systane Ultra, Alcon, Fort Worth, TX, USA) 4 times daily for at least 1 month.
In the implantable collamer lens group, lens power was calculated by the manufacturer using a modified vertex formula based on the manifest refraction. The size of the IOL was chosen based on the anterior chamber depth and the horizontal corneal diameter. Two paracenteses were performed at the 6- and 12 o’clock positions followed by injection of viscoelastic substance into the anterior chamber. A 3-mm temporal clear corneal incision was then performed and a V4c ICL model was inserted into the posterior chamber. Postoperative treatment included a combination of topical antibiotic and steroid drops (Tobradex, Novartis, Basel, Switzerland) 4 times daily for 4 weeks,
All patients were examined 1 day, 1 week, 1 month, and 3 months after the surgery. Results 3 months after the surgery were analyzed in this study. Evaluation included measurement of UCDVA, CDVA, manifest refraction, slit-lamp examination, tonometry, and fundus examination. In addition, fusion, stereoacuity, and horizontal and vertical aniseikonia was re-measured.
The collected data were coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 18.0, IBM Corp., Chicago, USA). Comparisons between paired and matched variables were done using Wilcoxon signed-rank test for paired 2-groups comparisons and Friedman test for comparisons between more than 2 groups. Comparisons between separate groups were done using Mann-Whitney test for 2 groups, and analysis of variance (ANOVA) repeated measures for more than 2 groups. Correlation between different parameters weas done using Pearson’s correlation coefficient.