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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Ophthalmic Consultants of Long Island

Brief 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.

Condition or disease
Cataract Dry Eye

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Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: Change from Screening to Month 3 ]
    Subject questionnaire

  2. Subject Dry Eye Questionnaire [ Time Frame: Change from Screening to Month 3 ]
    Subject questionnaire

  3. Artificial Tear Use [ Time Frame: Change from Screening to Month 3 ]
    Subject questionnaire

  4. 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.

  5. 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

  6. Best Corrected Visual Acuity (BCVA) [ Time Frame: Change from Screening to Month 3 ]
    Best Corrected Visual Acuity via eye chart examination

  7. Intraocular Pressure (IOP) [ Time Frame: Change from Screening to Month 3 ]
    Intraocular pressure via slit lamp examination

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Private Practice

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01441895

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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   
Sponsors and Collaborators
Ophthalmic Consultants of Long Island

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Responsible Party: Ophthalmic Consultants of Long Island Identifier: NCT01441895     History of Changes
Other Study ID Numbers: AGN02-FEMTO
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

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:
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Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Lens Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases