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IRCT20100706004333N4 IRCT 2021-11-22 Noor Eye Hospital Comparison of manual and automatic laser ablation in feto-LASIK Effect of eye-tracker system in FS-LASIK on optical zone centration: a contralateral randomized clinical trial 2021-11-22 anticipated 70 Complete https://irct.ir/trial/59640 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this contralateral clinical trial, two eyes of each patients randomly allocated in each study group by balanced block randomization (BBR) to achieve a best power in the analysis. BBR is used in a block size of 2 on the right eye of each patient. With this method, sequencing of eye-tracker and manual cods of right eye is detremined by a table of randome number and binary blocks. In this way, one eye of each patient will be allocated in the eye-tracker group and the other eye in the control group (without using eye-tracker). To concealment, randomization is performed by a non-surgeon. The technician was informed about the allocated group of each eyes at the time of surgery. The surgeon will be masked to the groups until to surgery time, Blinding description: The patints are masekd to the groups until the end of study. The surgeon is masked to each eye patient group until surgery. Also statistician and ophthalmic healthcare providers are masked to the treatment allocation of each eye. N/A Myopia. Intervention 1: In femtosecond assisted laser in situ keratomileusis (FS-LASIK), after topical anesthesia, the flap (110.0 µm thick) is created by Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap lift, wavefront-optimized ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany). The optical zone is 6.5 mm for moderate myopia, 6.0 mm for high myopia, and blend zone was 1.25 mm for all cases. Based on the random groups of each eye, the eye-tracker is turned on (with eye-tracker) and off (without eye-tracker) by the device engineer during ablation. Postoperative treatment regimen includes chloramphenicol eye drop 0.5% (Sina Darou, Tehran, Iran) every 6 hours to 3 days and betamethasone 0.1% eye drops (Sina Darou, Tehran, Iran) every 6 hours to 7 days. Intervention 2: In femtosecond assisted laser in situ keratomileusis (FS-LASIK), after topical anesthesia, the flap (110.0 µm thick) is created by Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap lift, wavefront-optimized ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany). The optical zone is 6.5 mm for moderate myopia, 6.0 mm for high myopia, and blend zone was 1.25 mm for all cases. Based on the random groups of each eye, the eye-tracker is turned on (with eye-tracker) and off (without eye-tracker) by the device engineer during ablation. Postoperative treatment regimen includes chloramphenicol eye drop 0.5% (Sina Darou, Tehran, Iran) every 6 hours to 3 days and betamethasone 0.1% eye drops (Sina Darou, Tehran, Iran) every 6 hours to 7 days. Yes - There is a plan to make this available What will be shared: The anonymous data will be available in case of reasonable request by corresponding author. When: 6 months after publication To whom: A member of a scientific board Conditions: For clinical or research utilization Where to obtain: Sending an email to the corresponding author / Hassan Hashemi (research@norc.ac.ir) Sending an email to the co-author / Soheila Asgari (soheilaasgari@gmail.com) How to obtain: Sending name and affiliation through an academic email Comments:
public Soheila Asgari
#96, Esfandiar Blvd., Valiasr Ave.
Tehran Iran (Islamic Republic of) 1968653111 +98 21 8240 1624 soheilaasgari@gmail.com Noor Eye Hospital scientific Soheila Asgari
#96, Esfandiar Blvd., Valiasr Ave.
Tehran Iran (Islamic Republic of) 1968653111 0098 82401624 soheilaasgari@gmail.com Noor Eye Hospital Iran (Islamic Republic of) myopia≥ 3.0D stable refraction in the past year (change ± 0.50 D or less) residual stromal bed thickness (RSB) of at least 300.0 µm 20 years 45 years Both Corneal ectasia H52.13 Myopia, bilateral Treatment - Surgery Treatment - Surgery In femtosecond assisted laser in situ keratomileusis (FS-LASIK), after topical anesthesia, the flap (110.0 µm thick) is created by Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap lift, wavefront-optimized ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany). The optical zone is 6.5 mm for moderate myopia, 6.0 mm for high myopia, and blend zone was 1.25 mm for all cases. Based on the random groups of each eye, the eye-tracker is turned on (with eye-tracker) and off (without eye-tracker) by the device engineer during ablation. Postoperative treatment regimen includes chloramphenicol eye drop 0.5% (Sina Darou, Tehran, Iran) every 6 hours to 3 days and betamethasone 0.1% eye drops (Sina Darou, Tehran, Iran) every 6 hours to 7 days. In femtosecond assisted laser in situ keratomileusis (FS-LASIK), after topical anesthesia, the flap (110.0 µm thick) is created by Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap lift, wavefront-optimized ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany). The optical zone is 6.5 mm for moderate myopia, 6.0 mm for high myopia, and blend zone was 1.25 mm for all cases. Based on the random groups of each eye, the eye-tracker is turned on (with eye-tracker) and off (without eye-tracker) by the device engineer during ablation. Postoperative treatment regimen includes chloramphenicol eye drop 0.5% (Sina Darou, Tehran, Iran) every 6 hours to 3 days and betamethasone 0.1% eye drops (Sina Darou, Tehran, Iran) every 6 hours to 7 days. Decentration of ablation zone from corneal vertex. Timepoint: 3 months after surgery. Method of measurement: Pachymetric map by Pentacam. Visual acuity. Timepoint: 3 months after surgery. Method of measurement: Snellen chart. Refraction. Timepoint: 3 months after surgery. Method of measurement: Retinoscope. Corneal aberrations. Timepoint: 3 months after surgery. Method of measurement: Pentacam. Noor Eye Hospital Approved 2021-10-27 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Faculty of medicine, Poursina Ave., Qods Ave., Enqelab Ave. Tehran Tehran Iran (Islamic Republic of)