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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Ophthalmic Consultants of Long Island.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier:
NCT01441895
First received: September 21, 2011
Last updated: November 16, 2012
Last verified: September 2011
  Purpose

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
Cataract
Dry Eye

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Ophthalmic Consultants of Long Island:

Primary Outcome Measures:
  • Change in Corneal Sensitivity Testing [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Ocular Surface Disease Index (OSDI) [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    Subject questionnaire

  • Subject Dry Eye Questionnaire [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    Subject questionnaire

  • Artificial Tear Use [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    Subject questionnaire

  • Corneal and Conjunctival Staining [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye

  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    Best Corrected Visual Acuity via eye chart examination

  • Intraocular Pressure (IOP) [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
    Intraocular pressure via slit lamp examination


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Private Practice

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441895

Locations
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    jfredrickson@ocli.net   
Sponsors and Collaborators
Ophthalmic Consultants of Long Island
Allergan
  More Information

No publications provided

Responsible Party: Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier: NCT01441895     History of Changes
Other Study ID Numbers: AGN02-FEMTO
Study First Received: September 21, 2011
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Long Island:
Refractive Cataract Extraction
Femtosecond laser
arcuate relaxing incisions
Dry Eye post cataract refraction

Additional relevant MeSH terms:
Cataract
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lens Diseases

ClinicalTrials.gov processed this record on April 17, 2014