Back to resultsHigher Irradiance in Keratoconus Ectasia
Primary Purpose
Keratoconus, Ectasia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UVA Light with irradiance exposure of 9 mW/cm2
Riboflavin 0.1% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK, irregular astigmatism
Eligibility Criteria
Inclusion Criteria:
Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
- 16 years of age or older
Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
- Characteristic pattern of deformity as analyzed by the Pentacam map.
- Minimal thickness of 350 microns
- The ability to sign a written informed consent
- States a willingness and ability to comply with schedule for follow-up visits
- Subject willing to remove contact lenses prior to evaluation and treatment
Inclusion criteria for ectasia
History of having undergone a keratorefractive procedure and show:
- Steepening by Pentacam study
- Thinning of cornea
- Shift in the position of thinnest portion of cornea
- Unstable refraction with increasing myopia and astigmatism
- Development of irregular astigmatism
- 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:
Subjects meeting any of the following criteria will be excluded from this protocol:
- Eyes classified as either normal or atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
- A history of delayed epithelial healing.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
- Inability to cooperate with diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Patients who are unable to remain supine and tolerate a lid speculum.
Sites / Locations
- Edward Harkness Eye Institute-Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
9 mw/cm2 at 10 minutes group
Arm Description
30 patients will be treated with UVA light source at 9 mw/cm2 at 10 minutes. Drug: Riboflavin Dose:1 drop every 2 to 3 minutes for 15 to 20 minutes
Outcomes
Primary Outcome Measures
Change in Total Optical Aberrations of the Cornea following Cross-Linking
Assessment of changes in corneal curvature, as analyzed using a Pentacam Scheimpflug Analyzer will be used in all patients. This allows measurement of corneal thickness, maximum and minimum curvatures and aberration analysis of the cornea as an optical element. The most significant objective measure of change is the total Higher Order Aberrations of the cornea and the Kmax, or steepest curvature of the cornea. Analysis of corneal curvature is directly related to improvement in the corneal shape which is directly related to visual function.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01789333
Brief Title
Higher Irradiance in Keratoconus Ectasia
Official Title
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen Trokel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Ectasia
Keywords
Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK, irregular astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
30 patients will be treated at 9 mw/cm2.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
9 mw/cm2 at 10 minutes group
Arm Type
Experimental
Arm Description
30 patients will be treated with UVA light source at 9 mw/cm2 at 10 minutes. Drug: Riboflavin Dose:1 drop every 2 to 3 minutes for 15 to 20 minutes
Intervention Type
Device
Intervention Name(s)
UVA Light with irradiance exposure of 9 mW/cm2
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Riboflavin 0.1% ophthalmic solution
Other Intervention Name(s)
Riboflavin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Total Optical Aberrations of the Cornea following Cross-Linking
Description
Assessment of changes in corneal curvature, as analyzed using a Pentacam Scheimpflug Analyzer will be used in all patients. This allows measurement of corneal thickness, maximum and minimum curvatures and aberration analysis of the cornea as an optical element. The most significant objective measure of change is the total Higher Order Aberrations of the cornea and the Kmax, or steepest curvature of the cornea. Analysis of corneal curvature is directly related to improvement in the corneal shape which is directly related to visual function.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
16 years of age or older
Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
Characteristic pattern of deformity as analyzed by the Pentacam map.
Minimal thickness of 350 microns
The ability to sign a written informed consent
States a willingness and ability to comply with schedule for follow-up visits
Subject willing to remove contact lenses prior to evaluation and treatment
Inclusion criteria for ectasia
History of having undergone a keratorefractive procedure and show:
Steepening by Pentacam study
Thinning of cornea
Shift in the position of thinnest portion of cornea
Unstable refraction with increasing myopia and astigmatism
Development of irregular astigmatism
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:
Subjects meeting any of the following criteria will be excluded from this protocol:
Eyes classified as either normal or atypical normal,
Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
A history of delayed epithelial healing.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
Inability to cooperate with diagnostic tests.
Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Patients who are unable to remain supine and tolerate a lid speculum.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Trokel, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Harkness Eye Institute-Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Higher Irradiance in Keratoconus Ectasia
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