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UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia

NCT01325298 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2011-03-29

No results posted yet for this study

Summary

The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.

Conditions

  • Keratoconus
  • Ectasia
  • Corneal Ectasia

Interventions

DEVICE

UV-X Light

UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%

DRUG

Riboflavin

Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.

DEVICE

UV-X Light

UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%

DRUG

Riboflavin

Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.

Sponsors & Collaborators

  • Mercy Center for Corrective Eye Surgery

    lead OTHER

Principal Investigators

  • Robert L Epstein, MD · Mercy Center for Corrective Eye Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-03-31
Completion
2014-05-31

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 NCT01325298 on ClinicalTrials.gov