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Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

NCT05027295 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-01-04

No results posted yet for this study

Summary

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies.

Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

Conditions

  • Keratoconus
  • Corneal Ectasia

Interventions

DRUG

riboflavin ophthalmic solution

Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.

DRUG

riboflavin ophthalmic solution

Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes

Sponsors & Collaborators

  • Cornea and Laser Eye Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2025-07-31
Completion
2025-07-31
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 NCT05027295 on ClinicalTrials.gov