Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2019
CompletedFirst Submitted
Initial submission to the registry
April 5, 2020
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedApril 18, 2022
January 1, 2022
1 year
April 5, 2020
April 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 year
Study Arms (1)
Photorefractive Keratectomy with Corneal Cross-Linking
EXPERIMENTALFor correction of refractive error
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shahid Beheshti Universitylead
- Negah Eye Centercollaborator
- Tehran University of Medical Sciencescollaborator
Study Sites (1)
Negah Eye Hospital
Tehran, 1544914599, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Azad sanginabadi, PhD
Iran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
April 5, 2020
First Posted
January 4, 2022
Study Start
March 5, 2018
Primary Completion
March 5, 2019
Study Completion
July 5, 2023
Last Updated
April 18, 2022
Record last verified: 2022-01