Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | September 2011 |
End Date: | December 2012 |
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
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.
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.
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.
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