Comparison of Standard vs. Accelerated Corneal Crosslinking

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2026-07-01

Brief Summary

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The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

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Detailed Description

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Conditions

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Keratoconus Ectasia Corneal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Accelerated

Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes

Group Type ACTIVE_COMPARATOR

riboflavin 0.1%

Intervention Type COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes

Standard

Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes

Group Type ACTIVE_COMPARATOR

Riboflavin 0.1%

Intervention Type COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes

Interventions

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riboflavin 0.1%

Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes

Intervention Type COMBINATION_PRODUCT

Riboflavin 0.1%

Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Documented keratoconus or ectasia after refractive surgery

Exclusion Criteria

* Insufficient corneal thickness
* Ocular condition that may predispose the eye to complications
* History of chemical injury or delayed epithelial healing
* Condition that would interfere with or prolong epithelial healing
* Known sensitivity to treatment medications
* Pregnancy

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No