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IRCT20180428039441N2 IRCT 2023-01-17 NOOR Eye Hospital Centration in refractive surgery Comparison of asymmetric offset versus pupil centered ablation in refractive surgery 2023-02-09 anticipated 60 Complete https://irct.ir/trial/67884 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, there will be two types of surgical methods, A and B, which represent Asymmetric offset and Pupil center, respectively. In each individual, the right eye will be randomly operated with one of these two methods and the opposite eye will be operated with another method. Balanced block randomization method will be used for random assignment of surgical procedure. This method will prevent any prediction of the order of intervention. The entire process of random assignment will be done by STATA software using the ralloc package. After determining the blocks with a size of 4, the type of treatment (A or B) specified by the software will determine the surgery method of the right eye, and the opposite eye will be operated by another method. For example, A, indicates that the right eye will be operated by the Asymmetric offset treatment and the left eye by the Pupil center method. It should be noted that, in order to the allocation concealment, the surgical method of each patient will be placed in a sealed envelope with a unique random code generated by the software. This ensures that the surgeon will be noticed the random sequence only when the envelope is opened, Blinding description: Patients are unaware of which eye is in the control or intervention group. Also, those who perform the tests (optometrist and the clinical ophthalmologist responsible for ocular examination) will also be unaware of which eye (intervention or placebo) is evaluating. N/A Centration of ablation profile in refractive surgery. Intervention 1: Intervention group: After local anesthesia, a flap (110 μm thick) is created using a Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap removal, ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany) with asymmetric offset centering. After the operation, chloramphenicol 0.5% Sina Daro drops will be prescribed 4 times a day for 3 days and betamethasone 0.1% Sina Daro 4 times a day for one week. Intervention 2: Control group: After local anesthesia, a flap (110 μm thick) is created using a Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap removal, ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany) with pupil center treatment. After the operation, chloramphenicol 0.5% Sina Daro drops will be prescribed 4 times a day for 3 days and betamethasone 0.1% Sina Daro 4 times a day for one week. No - There is not a plan to make this available Justification or reason for not sharing IPD is Per request, we will decide about the dissemination of the data
public Mojgan Pakbin
96, Esfandiar Blvd, Valiasr St.
Tehran Iran (Islamic Republic of) 1968653131 +98 21 8240 1675 m_pakbin@razi.tums.ac.ir NOOR EYE Hospital scientific Dr. Hassan Hashemi
96, Esfandiar Blvd, Valiasr St.
Tehran Iran (Islamic Republic of) 1968653131 +98 21 8240 1675 research@norc.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Femto-LASIK candidates in following criteria Age: 18-60 years Spherical Equivalent (SE): +400 to -6.00 Diopter Corrected distance visual acuity (CDVA): 9/10 or better HOA (higher order aberration) < 0.65 µm Pupil offset ≥ 0.2 mm (200 µm) Steady refractive errors (change < 0.5 diopter) during a year before Femto-LASIK Discontinuing soft contact lens and hard contact lens 1 and 4 weeks before the first examination, respectively 18 years 60 years Both A history of any ocular surgery Systematic diseases such as thyroid disease or diabetes Presence of cataract Glaucoma or intraocular pressure (IOP) > 21 mmHg Any corneal irregularity or opacity Any posterior segment disorders Pregnancy or breastfeeding Treatment - Surgery Treatment - Surgery Intervention group: After local anesthesia, a flap (110 μm thick) is created using a Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap removal, ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany) with asymmetric offset centering. After the operation, chloramphenicol 0.5% Sina Daro drops will be prescribed 4 times a day for 3 days and betamethasone 0.1% Sina Daro 4 times a day for one week. Control group: After local anesthesia, a flap (110 μm thick) is created using a Femto LDV (Ziemer Ophthalmic Systems AG, Port, Switzerland). After flap removal, ablation is performed using AMARIS 1050RS (SCHWIND, Munich, Germany) with pupil center treatment. After the operation, chloramphenicol 0.5% Sina Daro drops will be prescribed 4 times a day for 3 days and betamethasone 0.1% Sina Daro 4 times a day for one week. Uncorrected distance visual acuity (UDVA). Timepoint: Before and 6 months after surgery. Method of measurement: Snellen Chart. Corrected distance visual acuity (CDVA). Timepoint: Before and 6 months after surgery. Method of measurement: Trial frame, Snellen Chart. Safety index. Timepoint: 6 months after surgery. Method of measurement: Calculation based on UDVA. Efficacy index. Timepoint: 6 months after surgery. Method of measurement: Calculation based on UDVA and CDVA. Refraction. Timepoint: Before and 6 months after surgery. Method of measurement: Auto-refractometer, trial frame, Snellen chart. Corneal Aberrations. Timepoint: Before and 6 months after surgery. Method of measurement: Pentacam. NOOR Eye Hospital Approved 2022-12-19 Ethics committee of Tehran University of Medical Sciences University Central Building,Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)