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Higher Irradiance in Keratoconus Ectasia

NCT01789333 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-09

No results posted yet for this study

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.

Conditions

  • Keratoconus
  • Ectasia

Interventions

DEVICE

UVA Light with irradiance exposure of 9 mW/cm2

The device's light emitting diode (LED) is used to deliver a metered dose of Ultraviolet A (UVA) light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. The aperture setting will be set at 10 mm, and the eye will be irradiated for 10 minutes for the high irradiance exposure of 9 milliwatts (mW)/cm2. During the exposure, instillation of riboflavin will continue (1 drop every 3 minutes).

DRUG

Riboflavin 0.1% ophthalmic solution

The speculum is removed and one (1) drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 3 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined to assure the presence of a yellow flare in the anterior chamber, indicating riboflavin saturation of the corneal tissue. If the yellow flare is not detected, riboflavin will continue to be instilled until the presence of the yellow flare in the anterior chamber is confirmed. During UVA irradiation, instillation of riboflavin will be continued every 3 minutes. For a 30-minute pre-treatment and 30-minute irradiation, the total dose of riboflavin solution is approximately 32 drops, or 1.6 ml (1 drop = 0.05 ml; 1.6 mL = 1.6 mg riboflavin).

Sponsors & Collaborators

  • Stephen Trokel

    lead OTHER

Principal Investigators

  • Stephen Trokel, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Primary Completion
2022-12-30
Completion
2022-12-30

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 NCT01789333 on ClinicalTrials.gov