Hyperopic LASIK With Crosslinking Versus Standard LASIK

Not Applicable

Completed

• Conditions: Hyperopia
• Interventions: Procedure: LASIK

• Registration Number: NCT03224013
• Lead Sponsor: Minia University

Brief Summary

Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).

Detailed Description

Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.

Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

Study Timeline

• Study Start: 2016-01-18
• Primary Completion: 2017-05-12
• Status Verified: 2017-07
• Study Completion: 2017-07-12
• Study First Submitted: 2017-07-15
• Study First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

Exclusion Criteria

• Patients with previous intraocular or corneal surgery, active corneal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperopic LASIK only	LASIK	group 2: hyperopic customized LASIK only
Hyperopic LASIK with crosslinking	LASIK	group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking

Primary Outcome Measures

Name	Time	Method
assessment of changes in refractive spherical equivalent	preoperative and 3 months and 6 months postoperative	assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent