Effect of Controlled Adverse Environment (CAE) on Tear Film Stability
The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||A Single-Center Study Evaluating the Effect of the Controlled Adverse Environment (CAE) on Tear Film Stability Using the OPI 2.0 System, Ocular Protection Index (OPI), Tear Film Break-Up Time (TFBUT) and Mean Break up Area by Region (MBA) in Patients Diagnosed With Dry Eye Evaluated During Their Natural Blink Pattern|
- change in tear film break up area [ Time Frame: change from baseline in tear film break up area at 30 minutes post-CAE at study visit ] [ Designated as safety issue: No ]
- change in Fluorescein Staining [ Time Frame: change from baseline in staining at 30 minutes post-CAE ] [ Designated as safety issue: No ]
- Change in Tear film break up time (TFBUT) [ Time Frame: change from baseline in tear film break up time at 30 minutes post-CAE ] [ Designated as safety issue: No ]
- Change in Conjunctival Redness [ Time Frame: change from baseline in conjunctival redness at 30 minutes post-CAE ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Single-Center, Pilot, controlled adverse environment (CAE) Study.
This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure.
All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547936
|United States, Massachusetts|
|Andover Eye Associates|
|Andover, Massachusetts, United States, 01810|
|Principal Investigator:||Tarek Shazly, MD||Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society|