Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser
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|ClinicalTrials.gov Identifier: NCT01441895|
Recruitment Status : Recruiting
First Posted : September 28, 2011
Last Update Posted : April 25, 2016
The study objective is to assess changes in corneal sensation and dry eye signs and symptoms following cataract extraction/femtosecond arcuate relaxing incisions.
Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or worsening of dry eye signs and symptoms.
|Condition or disease|
|Cataract Dry Eye|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A Post Market Pilot Study To Evaluate Corneal Sensation And The Incidence Of Dry Eye In Subjects Undergoing Refractive Cataract Extraction With The Femtosecond Laser For Arcuate Relaxing Incisions|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
- Change in Corneal Sensitivity Testing [ Time Frame: Change from Screening to Month 3 ]Subject lies supine with the test line of the Cochet-Bonnet Aesthesiometer suspended over the cornea to measure the sensation of touch on the eye. Testing is done in a standard manner by an experienced operator.
- Ocular Surface Disease Index (OSDI) [ Time Frame: Change from Screening to Month 3 ]Subject questionnaire
- Subject Dry Eye Questionnaire [ Time Frame: Change from Screening to Month 3 ]Subject questionnaire
- Artificial Tear Use [ Time Frame: Change from Screening to Month 3 ]Subject questionnaire
- Corneal and Conjunctival Staining [ Time Frame: Change from Screening to Month 3 ]Clinical assessment of Dry Eye severity on the cornea via the use of fluorescein dye and on the conjunctiva via the use of lissamine green dye.
- Tear Break Up Time (TBUT) with Biomicroscopy [ Time Frame: Change from Screening to Month 3 ]Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye
- Best Corrected Visual Acuity (BCVA) [ Time Frame: Change from Screening to Month 3 ]Best Corrected Visual Acuity via eye chart examination
- Intraocular Pressure (IOP) [ Time Frame: Change from Screening to Month 3 ]Intraocular pressure via slit lamp examination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441895
|United States, New York|
|Ophthlamic Consultants of Long Island - Rockville Centre||Recruiting|
|Rockville Centre, New York, United States, 11570|
|Contact: Joan Fredrickson 516-705-7140 firstname.lastname@example.org|