Status:
ACTIVE_NOT_RECRUITING
Epi-on PiXL for the Treatment of Progressive Keratoconus.
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Glaukos Corporation
Conditions:
Keratoconus
Corneal Crosslinking
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by individually customized Photorefractive intrastromal crosslinking (PiXL) without epithelium debride...
Detailed Description
The study is designed as a prospective, open-label, nonrandomized trial involving participants of both genders aged 18-35 years with Keratoconus planned for routine corneal crosslinking at the Departm...
Eligibility Criteria
Inclusion
- Patients planned for corneal crosslinking.
- Progressive keratoconus documented with a consistent decrease of best corrected visual acuity with no other explanation, an unquestionable historical progression, or a progression documented with the Pentacam Scheimpflug camera with at least 2 of the following: progressive anterior and/or posterior corneal steepening and/or progressive corneal thinning and/or increased rate of corneal thickness change from the periphery to the center.
- A keratoconus diagnosis based on abnormal posterior elevation, abnormal corneal thickness distribution and clinical noninflammatory corneal thinning using the "Belin/Ambrósio enhanced ectasia" measurements of the Pentacam Scheimpflug camera.
- Minimum corneal thickness of 400 µm at the thinnest point before epithelial removal.
- 18-35 years of age
- No ocular abnormalities except keratoconus
- No previous ocular surgery
- No cognitive insufficiency interfering with the informed consent.
Exclusion
- Age under 18 or over 35
- Any corneal abnormalities except keratoconus
- Pregnancy or lactation
- Previous ocular surgery
- Cognitive insufficiency
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04668924
Start Date
March 20 2019
End Date
February 5 2026
Last Update
December 20 2023
Active Locations (1)
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1
Umeå University Hospital
Umeå, Sweden, 90185