Corneal Crosslinking in Keratoconus and Corneal Ectasia

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

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Detailed Description

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After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Conditions

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Progressive Keratoconus Corneal Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sham treatment

Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.

Treatment Arm

After randomization, the active arm will have the collagen crosslinking intervention.

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes

Interventions

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Riboflavin

01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes

Intervention Type DRUG

Placebo

Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.

Intervention Type DRUG

Other Intervention Names

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Vitamin B2

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of keratoconus with documented progression over the previous 12 months.
* Diagnosis of corneal ectasia
* Must be able to complete all study visits.