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Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

NCT04897503 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-01-04

No results posted yet for this study

Summary

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Conditions

  • Keratoconus
  • Corneal Ectasia

Interventions

DRUG

Riboflavin

Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

Sponsors & Collaborators

  • Cornea and Laser Eye Institute

    lead OTHER

Principal Investigators

  • Peter S Hersh, MD · Cornea and Laser Eye Institute Hersh Vision Group

  • Steven A Greenstein, MD · Cornea and Laser Eye Institute, Hersh Vision Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897503 on ClinicalTrials.gov