Comparison of Standard vs. Accelerated Corneal Crosslinking

Phase 2

Recruiting

• Conditions: Ectasia Corneal; Keratoconus
• Interventions: Combination Product: Riboflavin 0.1%

• Registration Number: NCT03922542
• Lead Sponsor: Price Vision Group

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 510

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated	Riboflavin 0.1%	Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
Standard	Riboflavin 0.1%	Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes

Primary Outcome Measures

Name	Time	Method
Change in maximum keratometry	6 months	assessed by corneal tomography

Secondary Outcome Measures

Name	Time	Method
Change in uncorrected distance visual acuity	6 months	assessed with Snellen chart
Change in corrected distance visual acuity	6 months	assessed with Snellen chart

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States