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Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Sponsor
Shahid Beheshti University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05176171
Collaborator
Negah Eye Center (Other), Tehran University of Medical Sciences (Other)
50
Enrollment
1
Location
1
Arm
64
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Photorefractive Keratectomy with Corneal Cross-Linking
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Actual Study Start Date :
Mar 5, 2018
Actual Primary Completion Date :
Mar 5, 2019
Anticipated Study Completion Date :
Jul 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Photorefractive Keratectomy with Corneal Cross-Linking

For correction of refractive error

Procedure: Photorefractive Keratectomy with Corneal Cross-Linking
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.

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [3 year]

    Evaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Negah Eye Hospital Tehran Iran, Islamic Republic of 1544914599

Sponsors and Collaborators

  • Shahid Beheshti University
  • Negah Eye Center
  • Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Azad sanginabadi, PhD, Iran University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
farinaz doroodgar, Ophthalmologist, Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT05176171
Other Study ID Numbers:
  • SBMU
First Posted:
Jan 4, 2022
Last Update Posted:
Apr 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Keratoconus

Study Results

No Results Posted as of Apr 18, 2022