Higher Irradiance in Keratoconus Ectasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Stephen Trokel, Columbia University
ClinicalTrials.gov Identifier:
NCT01789333
First received: November 20, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to see if brighter lights will allow us to shorten 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 B12 and the investigators are trying to determine if they can get an identical clinical effect when they use the brighter treatment lights 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.


Condition Intervention
Keratoconus
Ectasia
Device: UVA Light with irradiance exposure of 9 mW/cm2
Drug: Riboflavin 0.1% ophthalmic solution
Device: UVA Light with irradiance exposure of 18 mW/cm2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in Total Optical Aberrations of the Cornea following Cross-Linking [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The change in corneal topography and optical properties from baseline will be evaluated at 3 and 6 months for all eyes.


Secondary Outcome Measures:
  • Change in Uncorrected Visual Acuity (UCVA) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Manifest Refraction [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in depth of the effect with Optical Coherence Tomography (OCT) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    To assess the hypothesis the higher irradiance produces the same pattern of change, we will measure the depth and intensity of the stromal changes using Optical Coherence Tomography. An identical pattern of depth and intensity o fstromal change in the cornea for both the low and high irradiances will demonstrate that the nature of the photochemical interaction is identical. If, on the other hand, the higher irradiance creates a different effect as seen on the OCT, then the hypothesis of equivalence must be questioned.


Estimated Enrollment: 6
Study Start Date: August 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 9 mw/cm2 group
Three patients will be treated at 9 mw/cm2.
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 UV-A 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 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).

Other Name: Riboflavin
18 mw/cm2 group
Three patients will be treated at 9 mw/cm2. If the endothelial studies show no damage then the next three patients will be treated at 18 mw/cm2.
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).

Other Name: Riboflavin
Device: UVA Light with irradiance exposure of 18 mW/cm2

The device's light emitting diode (LED) is used to deliver a metered dose of UV-A 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 5 minutes at 18 mW/cm2. During the exposure, instillation of riboflavin will continue (1 drop every 3 minutes).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:

  1. 18 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. Signed written informed consent
  4. Willingness and ability to comply with schedule for follow-up visits
  5. Contact lens removal prior to evaluation and treatment

Inclusion criteria for ectasia

  1. History of having undergone a keratorefractive procedure and:

    1. Steepening by topography, either Pentacam or Humphrey
    2. Thinning of cornea
    3. Shift in the position of thinnest portion of cornea
    4. Unstable refraction with increasing myopia and astigmatism
    5. Development of irregular astigmatism
  2. At least two of the above criteria must be present.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from this study:

  1. Eyes classified as either normal, atypical normal,
  2. Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam.
  3. A history of chemical injury or 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 would prevent a 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.
  9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
  10. Patients who are unable to remain supine and tolerate a lid speculum.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789333

Contacts
Contact: MaEdylin Bautista 212-305-5922 mmb2225@columbia.edu

Locations
United States, New York
Edward Harkness Eye Institute-Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: MaEdylin Bautista    212-305-5922    mmb2225@columbia.edu   
Principal Investigator: Stephen Trokel, MD         
Sponsors and Collaborators
Stephen Trokel
Investigators
Principal Investigator: Stephen Trokel, MD Columbia University
  More Information

No publications provided

Responsible Party: Stephen Trokel, Professor of Clinical Ophthalmology, Columbia University
ClinicalTrials.gov Identifier: NCT01789333     History of Changes
Other Study ID Numbers: AAAF4157
Study First Received: November 20, 2012
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Keratoconus
Ectasia
UVA light
riboflavin
post-LASIK
irregular astigmatism

Additional relevant MeSH terms:
Riboflavin
Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014