Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser
Verified April 2016 by Ophthalmic Consultants of Long Island
Information provided by (Responsible Party):
Ophthalmic Consultants of Long Island
First received: September 21, 2011
Last updated: April 22, 2016
Last verified: April 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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- Ocular Surface Disease Index (OSDI) [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
- Subject Dry Eye Questionnaire [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
- Artificial Tear Use [ Time Frame: Change from Screening to Month 3 ] [ Designated as safety issue: No ]
- 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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441895
|Ophthlamic Consultants of Long Island - Rockville Centre
|Rockville Centre, New York, United States, 11570 |
|Contact: Joan Fredrickson 516-705-7140 email@example.com |
Ophthalmic Consultants of Long Island
||Ophthalmic Consultants of Long Island
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2011
||April 22, 2016
||United States: Institutional Review Board
Keywords provided by Ophthalmic Consultants of Long Island:
Refractive Cataract Extraction
arcuate relaxing incisions
Dry Eye post cataract refraction
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2016
Dry Eye Syndromes
Lacrimal Apparatus Diseases