Hyperopic LASIK With Crosslinking Versus Standard LASIK

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT03224013

Collaborator

(none)

Enrollment

Arms

17.8

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hyperopia	Procedure: LASIK	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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 +1D to +6D or hyperopic astigmatism up to 4D 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 measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.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 +1D to +6D or hyperopic astigmatism up to 4D 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 measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes

Actual Study Start Date :

Jan 18, 2016

Actual Primary Completion Date :

May 12, 2017

Actual Study Completion Date :

Jul 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hyperopic LASIK with crosslinking group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking	Procedure: LASIK LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye
Active Comparator: Hyperopic LASIK only group 2: hyperopic customized LASIK only	Procedure: LASIK LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye

Arm

Intervention/Treatment

Active Comparator: Hyperopic LASIK with crosslinking

group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking

Procedure: LASIK

LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye

Active Comparator: Hyperopic LASIK only

group 2: hyperopic customized LASIK only

Procedure: LASIK

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 61 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Minia University

Investigators

Study Director: Jorge L Alio, MD, MD, Phd, FEBO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahemd Abdelghany, Lecturer of Ophthalmology.Faculty of Medicine, Minia University

ClinicalTrials.gov Identifier:

NCT03224013

Other Study ID Numbers:

Hyperopic LASIK

First Posted:

Jul 21, 2017

Last Update Posted:

Jul 21, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperopia

Study Results

No Results Posted as of Jul 21, 2017