Back to resultsSurface Ablation With Corneal Cross Linking in Mild Keratoconus
Primary Purpose
Keratoconus, Corneal Cross-Linking
Status
Active
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Photorefractive Keratectomy with Corneal Cross-Linking
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of >410 µm.
exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.
Sites / Locations
- Negah Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photorefractive Keratectomy with Corneal Cross-Linking
Arm Description
For correction of refractive error
Outcomes
Primary Outcome Measures
Visual Acuity
Evaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05176171
First Posted
April 5, 2020
Last Updated
April 10, 2022
Sponsor
Shahid Beheshti University
Collaborators
Negah Eye Center, Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05176171
Brief Title
Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Official Title
Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
July 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
Collaborators
Negah Eye Center, Tehran University of Medical Sciences
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
Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) will be divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures will be pre-and postoperative uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Corneal Cross-Linking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photorefractive Keratectomy with Corneal Cross-Linking
Arm Type
Experimental
Arm Description
For correction of refractive error
Intervention Type
Procedure
Intervention Name(s)
Photorefractive Keratectomy with Corneal Cross-Linking
Intervention Description
To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Evaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation.
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of >410 µm.
exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azad sanginabadi, PhD
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Negah Eye Hospital
City
Tehran
ZIP/Postal Code
1544914599
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Surface Ablation With Corneal Cross Linking in Mild Keratoconus
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