Loading clinical trials...

Higher Irradiance in Keratoconus Ectasia | Clinical Trials | Clareo Health

WITHDRAWNNA

Higher Irradiance in Keratoconus Ectasia

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia

NCT01789333•Stephen Trokel

View on ClinicalTrials.gov

Summary

The purpose of the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. The investigators will be comparing the therapeutic effects of two different higher brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as bright as the other and the exposure time of these brighter lights to deliver equivalent energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes. Riboflavin is vitamin B2 and the investigators are trying to determine if an identical clinical effect can be achieved the brighter treatment lights are used for shorter times. The investigators will also monitor the clinical effect and the status of the cornea to see if additional risks are associated with the brighter light.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
•1. 16 years of age or older
•2. Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
•1. Characteristic pattern of deformity as analyzed by the Pentacam map.
•2. Minimal thickness of 350 microns
•3. The ability to sign a written informed consent
•4. States a willingness and ability to comply with schedule for follow-up visits
•5. Subject willing to remove contact lenses prior to evaluation and treatment
•1. History of having undergone a keratorefractive procedure and show:
•1. Steepening by Pentacam study
+5 more criteria

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from this study:
•Subjects meeting any of the following criteria will be excluded from this protocol:
•1. Eyes classified as either normal or atypical normal,
•2. Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
•3. A history of delayed epithelial healing.
•4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
•5. A known sensitivity to study medications
•6. Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
•7. Inability to cooperate with diagnostic tests.
•8. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
+1 more criteria

Locations (1)

Edward Harkness Eye Institute-Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

December 30, 2022

Completion Date

December 30, 2022

Last Updated

February 9, 2023

Conditions

KeratoconusEctasia

Interventions

UVA Light with irradiance exposure of 9 mW/cm2

DEVICE

Riboflavin 0.1% ophthalmic solution

DRUG

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

NCT06306963

Gastric Antral Vascular EctasiaCirrhosis+1 more

View study

RECRUITINGNA

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

NCT07372911

Keratoconus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Higher Irradiance in Keratoconus Ectasia

Inclusion Criteria

Exclusion Criteria

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

Institutional Registry of Rare Diseases

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia