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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01441895
• Date of registration: 21/09/2011
• Primary sponsor: Ophthalmic Consultants of Long Island
• Public title: Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser
• Scientific 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
• Date of first enrolment: September 2011
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01441895
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Joan Fredrickson

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects 18 years or older, in good general health

- Prior to signing the IRB approved Informed Consent Form / HIPAA 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 2.5D 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cataract

Dry Eye

Primary Outcome(s)

Change in Corneal Sensitivity Testing [Time Frame: Screening, Week 1, Month 1 Month 3]

Secondary Outcome(s)

Artificial Tear Use [Time Frame: Screening, Week 1, Month 1, Month 3]

Best Corrected Visual Acuity (BCVA) [Time Frame: Screening, Week 1, Month 1, Month 3]

Corneal and Conjunctival Staining [Time Frame: Screening, Day 1, Week 1, Month 1, Month 3]

Intraocular Pressure (IOP) [Time Frame: Screening, Day 1, Week 1, Month 1, Month 3]

Ocular Surface Disease Index (OSDI) [Time Frame: Screening , Week 1, Month 1, Month 3]

Subject Dry Eye Questionnaire [Time Frame: Screening, Week 1, Month 1, Month 3]

Tear Break Up Time (TBUT) with Biomicroscopy [Time Frame: Screening, Week 1, Month 1, Month 3]

Secondary ID(s)

AGN02-FEMTO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Allergan