Treatment of Keratoconus With Advanced CXL-II
Launched by UMEÅ UNIVERSITY · Jul 30, 2015
Trial Information
Current as of April 27, 2025
Unknown status
Keywords
ClinConnect Summary
The study is designed as a prospective, open label, randomized controlled trial involving patients aged 12 years or older of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking (CXL) at the Department of Clinical Sciences / Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 25+25 eyes with keratoconus, which are randomized to receive either conventional pulsed crosslinking with a uniform, universal 8 mm treatment pattern of 5.4 J/cm2 (pCXL; n=25), or a modified treatment - individualized topography-based corneal crosslinking (KXL2;...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients planned for corneal crosslinking.
- • 2. Uni-or bilateral keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" keratoconus quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam HR® Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
- • 3. Progression of the keratoconus in the eye in question, documented with Scheimpflug photography using the Oculus Pentacam HR® Scheimpflug camera and/or repeated subjective refraction and keratometry.
- • 4. Minimum corneal thickness of 400 μm at the thinnest point after epithelial removal.
- • 5. ≥12 years of age
- • 6. No ocular abnormalities except keratoconus
- • 7. No previous ocular surgery
- • 8. No cognitive insufficiency interfering with the informed consent.
- Exclusion Criteria:
- • 1. Age under 12
- • 2. Any corneal abnormalities except keratoconus
- • 3. Previous ocular surgery
- • 4. Cognitive insufficiency
About Umeå University
Umeå University, a leading research institution in Sweden, is dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on interdisciplinary collaboration, the university harnesses cutting-edge technology and expert knowledge across various fields to address critical health challenges. Its commitment to ethical standards and patient safety ensures that all clinical trials conducted under its auspices are designed to generate robust scientific evidence, ultimately contributing to improved health outcomes and informed medical practices. Umeå University strives to foster a dynamic research environment that supports the development of new therapies and enhances the understanding of complex health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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