Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser

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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract; Dry Eye

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • New York
    • Rockville Centre, New York, United States, 11570
      • Recruiting
      • Ophthlamic Consultants of Long Island - Rockville Centre
      • Contact: Joan Fredrickson; Phone Number: 516-705-7140; Email: jfredrickson@ocli.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Private Practice

Description

Inclusion Criteria:

• Male or female subjects 18 years or older, in good general health
• Prior to signing the Institutional Review Board approved Informed Consent Form / Health Insurance Portability and Accountability Act subject read and gained an understanding of the contents
• Subject scheduled for cataract extraction with intraocular lens and requiring two (2) femtosecond arcuate relaxing incisions for correction of corneal astigmatism
• Subject has greater than or equal to 1.0 D and less than or equal to 2.5 Diopters of corneal astigmatism as measured by keratometry or corneal topography
• Two (2) arcuate incisions should be 45° in length and 180° apart.
• All arcuate relaxing incisions will be placed exactly 4.5 mm from the visual axis for a 9 mm optical zone.
• Corneal sensation at Screening by Cochet-Bonnet Aesthesiometry with floor stand >50 mm in all five regions
• Be willing / able to return for all required study visits and comply with instructions given by study staff
• Potential for best corrected visual acuity post cataract surgery of 20/20

Exclusion Criteria:

• Uncontrolled inflammation not related to dry eye
• Corneal abnormality that can affect corneal sensation or tear film stability (except superficial punctate keratitis (SPK)).
• History of ophthalmic herpes simplex or zoster keratitis
• OSDI score > 32
• Active ocular allergy
• History of refractive surgery or any surgery involving conjunctival, arcuate or corneal incision
• Contact lens wear during the study. Soft contact lens wearers should discontinue use at least two weeks prior to Screening visit. Rigid gas permeable (RGP) or hard contact lens wearers should discontinue use at least one month prior to Screening visit.
• Dry eye secondary to Vitamin A deficiency, scarring, pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation.
• Currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
• Use of topical cyclosporine (Restasis) within three months of Screening visit.
• Have an uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurological disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
• Temporary or permanent occlusion of the lacrimal puncta
• Require chronic use of systemic medications which may induce or affect a dry eye condition (e.g., anticholinergics, cyclosporine, antihistamines, antimuscarinics, beta-blocking agents, tricyclic antidepressants, phenothiazines, estrogen-progesterone, and other estrogen derivatives), unless that medication has been used in the same dose for at least 3 months and is expected to remain constant for the course of the study
• Current or anticipated use of nutritional supplements (e.g. flax seed oil, fish oil, omega-3 supplements) which may affect a dry eye condition.
• Are currently enrolled in any other clinical study or have participated in such a study within 30 days of entry into this study
• Is pregnant, breast-feeding, planning a pregnancy, or not using a reliable method of contraception. Subjects who become pregnant during the study will be discontinued from further study participation.
• Have a condition or are in a situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with their participation in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Corneal Sensitivity Testing	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.	Change from Screening to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index (OSDI)	Subject questionnaire	Change from Screening to Month 3
Subject Dry Eye Questionnaire	Subject questionnaire	Change from Screening to Month 3
Artificial Tear Use	Subject questionnaire	Change from Screening to Month 3
Corneal and Conjunctival Staining	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.	Change from Screening to Month 3
Tear Break Up Time (TBUT) with Biomicroscopy	Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye	Change from Screening to Month 3
Best Corrected Visual Acuity (BCVA)	Best Corrected Visual Acuity via eye chart examination	Change from Screening to Month 3
Intraocular Pressure (IOP)	Intraocular pressure via slit lamp examination	Change from Screening to Month 3

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of Long Island
• Collaborators: Allergan

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (ESTIMATE): September 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Femtosecond laser; Refractive Cataract Extraction; arcuate relaxing incisions; Dry Eye post cataract refraction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: AGN02-FEMTO