Centration in refractive surgery

Not Applicable

• Conditions: Centration of ablation profile in refractive surgery.

• Registration Number: IRCT20180428039441N2
• Lead Sponsor: OOR Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ncorrected 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.

Secondary Outcome Measures

Name	Time	Method
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.