Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- evaluation of depth of demarcation line
Study Overview
Brief Summary
To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients
Detailed Description
Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •progressive keratoconus stage 1-2
Exclusion Criteria
- •any concomitant ocular disease
Arms & Interventions
Epithelium-off accelerated cross-linking
Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes
Intervention: corneal cross-linking (Procedure)
Transepithelial accelerated cross-linking
Paracel is instilled 1 drop every 1.5 minutes for 4.5 minutes then vibex-xtra is instilled 4 drops at 5.5 minutes followed by 1 drop at 6.5 minutes for a total soak time of 11 minutes followed by ultraviolet-A" UVA" irradiation with intended irradiance of 45mW/cm2 for 2.4 minutes
Intervention: corneal cross-linking (Procedure)
Outcomes
Primary Outcomes
evaluation of depth of demarcation line
Time Frame: 1 month postoperative
Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line
Secondary Outcomes
No secondary outcomes reported
Investigators
Sarah Akram Azzam
Principal investigator
Kasr El Aini Hospital