Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Brief Summary

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This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

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Detailed Description

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This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Conditions

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Progressive Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Corneal collagen cross-linking with riboflavin and UVA light

Group Type EXPERIMENTAL

Corneal collagen cross-linking with riboflavin/UVA light

Intervention Type OTHER

Corneal collagen cross-linking with riboflavin/UVA light

Interventions

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Corneal collagen cross-linking with riboflavin/UVA light

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 6 to 18 years
* Having a diagnosis of progressive keratoconus
* Signed written informed consent
* Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria

* Corneal pachymetry at the screening exam that is \<400 microns at the thinnest point
* Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
* A history of delayed epithelial healing in the eye(s) to be treated
* Pregnancy or lactation during the course of the study
* A known sensitivity to study medications

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No