Higher Irradiance in Keratoconus Ectasia
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|ClinicalTrials.gov Identifier: NCT01789333|
Recruitment Status : Recruiting
First Posted : February 12, 2013
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus Ectasia||Device: UVA Light with irradiance exposure of 9 mW/cm2 Drug: Riboflavin 0.1% ophthalmic solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||30 patients will be treated at 9 mw/cm2.|
|Masking:||None (Open Label)|
|Official Title:||Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: 9 mw/cm2 at 10 minutes group
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
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
- Change in Total Optical Aberrations of the Cornea following Cross-Linking [ Time Frame: Baseline to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789333
|Contact: MaEdylin Bautistafirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Stephen Trokel, MD|
|Principal Investigator:||Stephen Trokel, MD||Columbia University|