Hyperopic LASIK With Crosslinking Versus Standard LASIK
Primary Purpose
Hyperopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LASIK
Sponsored by
About this trial
This is an interventional other trial for Hyperopia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hyperopic LASIK with crosslinking
Hyperopic LASIK only
Arm Description
group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking
group 2: hyperopic customized LASIK only
Outcomes
Primary Outcome Measures
assessment of changes in refractive spherical equivalent
assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03224013
Brief Title
Hyperopic LASIK With Crosslinking Versus Standard LASIK
Official Title
Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 18, 2016 (Actual)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
July 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperopic LASIK with crosslinking
Arm Type
Active Comparator
Arm Description
group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking
Arm Title
Hyperopic LASIK only
Arm Type
Active Comparator
Arm Description
group 2: hyperopic customized LASIK only
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
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
Primary Outcome Measure Information:
Title
assessment of changes in refractive spherical equivalent
Description
assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
Time Frame
preoperative and 3 months and 6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge L Alio, MD
Organizational Affiliation
MD, Phd, FEBO
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperopic LASIK With Crosslinking Versus Standard LASIK
We'll reach out to this number within 24 hrs