Comparison of Standard vs. Accelerated Corneal Crosslinking

Phase 3RecruitingNCT03922542

Price Vision Group510 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

510

Conditions

Keratoconus Ectasia Corneal

Interventions

riboflavin 0.1%COMBINATION_PRODUCT

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

Riboflavin 0.1%COMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Price Vision Group

Indianapolis, Indiana, United States

RECRUITING

Outcomes

Primary Outcomes

Change in maximum keratometry

assessed by corneal tomography

Time frame: 6 months

Secondary Outcomes

Change in corrected distance visual acuity

assessed with Snellen chart

Time frame: 6 months

Change in uncorrected distance visual acuity

assessed with Snellen chart

Time frame: 6 months

Central Contacts

Marianne Price, PhD

CONTACT

317-814-2990 mprice@cornea.org

Data from ClinicalTrials.gov

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