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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01441895
• Other study ID #: AGN02-FEMTO
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2011
• Last updated: April 22, 2016
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Ophthalmic Consultants of Long Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Ophthlamic Consultants of Long Island - Rockville Centre	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Long Island	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ocular Surface Disease Index (OSDI)	Subject questionnaire	Change from Screening to Month 3	No
Secondary	Subject Dry Eye Questionnaire	Subject questionnaire	Change from Screening to Month 3	No
Secondary	Artificial Tear Use	Subject questionnaire	Change from Screening to Month 3	No
Secondary	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	No
Secondary	Tear Break Up Time (TBUT) with Biomicroscopy	Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye	Change from Screening to Month 3	No
Secondary	Best Corrected Visual Acuity (BCVA)	Best Corrected Visual Acuity via eye chart examination	Change from Screening to Month 3	No
Secondary	Intraocular Pressure (IOP)	Intraocular pressure via slit lamp examination	Change from Screening to Month 3	No