Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser
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|ClinicalTrials.gov Identifier: NCT01441895|
Recruitment Status : Unknown
Verified April 2016 by Ophthalmic Consultants of Long Island.
Recruitment status was: 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
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): 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|