Overview

This trial is active, not recruiting.

Condition keratoconus
Treatments corneal reshaping/crosslinking (crxl), corneal crosslinking (cxl)
Phase phase 2
Sponsor Umeå University
Start date October 2009
End date October 2017
Trial size 120 participants
Trial identifier NCT02425150, CRXL

Summary

The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.
corneal reshaping/crosslinking (crxl)
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
(Active Comparator)
Standard corneal crosslinking using the Dresden protocol.
corneal crosslinking (cxl)
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
(No Intervention)
Healthy subjects, age- and sex-matched to the CRXL group.
(No Intervention)
Healthy subjects, age- and sex-matched to the CXL group.

Primary Outcomes

Measure
Change from baseline in refraction
time frame: 1, 6, 24 and 60 months after the treatment

Secondary Outcomes

Measure
Change from baseline in ETDRS LogMAR visual acuity
time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ORA
time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ART
time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with GAT
time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal densitometry
time frame: 1, 6, 24 and 60 months after the treatment

Eligibility Criteria

Male or female participants from 18 years up to 28 years old.

Inclusion Criteria: - Patients planned for corneal crosslinking. - Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry. - A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires. - Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal. - 18-28 years of age - No ocular abnormalities except keratoconus - No previous ocular surgery - No cognitive insufficiency interfering with the informed consent. Exclusion Criteria: - Age under 18 or over 28 - Any corneal abnormalities except keratoconus - Previous ocular surgery - Cognitive insufficiency.

Additional Information

Official title Treatment of Keratoconus With Advanced Corneal Crosslinking
Principal investigator Anders Behndig, Professor
Description The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects. At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Umeå University.