A Phase 3 interventional study of Riboflavin and Riboflavin in Keratoconus and Corneal Ectasia, sponsored by Cornea and Laser Eye Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Cornea and Laser Eye Institute · Phase 3, Interventional, and Treatment
Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During previous studies of the CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.
The objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 160 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Cornea and Laser Eye Institute is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of riboflavin every 2 minutes for the duration of UV exposure.
Drug: Riboflavin
Administration of riboflavin every 1 minute for the duration of UV exposure.
Drug: Riboflavin
Administration of riboflavin every 2 minutes for the duration of UV exposure.
Also known as: Riboflavin without dextran
Administration of riboflavin every 1 minute for the duration of UV exposure.
Also known as: Riboflavin without Dextran
Maximum Keratometry
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint, the change in maximum keratometry (Kmax) from baseline will be evaluated at 1, 3 and 6 month for all eyes
Time frame: 12 months
Manifest refraction
The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As a secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3, and 6 months to look at the effect of wound healing on this variable.
Time frame: 12 months
Visual Acuity
Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1, 3, and 6 months following the CXL procedure will be analyzed.
Time frame: 12 months
Endothelial cell density
Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.
Time frame: 12 months
This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Riboflavin
Cornea and Laser Eye Institute