Status:
UNKNOWN
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL
Lead Sponsor:
Sight Medical Doctors PLLC
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry...
Detailed Description
This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry...
Eligibility Criteria
Inclusion
- Demonstrate objective signs of Boderline/ Mild Ocular Surface Disease (OSD) \[defined as mild symptoms, mild conjunctival staining (\<2+ Superficial Punctate Keratitis), Tear Break-up Time \<12s\] or demonstrate symptoms of OSD determined by SPEED questionnaire (SPEED Score \<10).
- Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
- Ability to provide informed consent for procedures
- Ability to attend scheduled follow up visits
- No other corneal pathology to create unknown variability
Exclusion
- Age less than 18
- Pregnancy/currently breast-feeding
- Inability to provide informed consent
- Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
- Punctal stenosis
- Previous corneal transplant surgery or refractive surgery
- Concurrent use of topical steroid eye drops
- Systemic, topical or intravitreal steroid use within 1 month of baseline
- Active history of chronic or recurrent inflammatory eye disease in either eye
- History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
- History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
- Diagnosis of Glaucoma or use of topical glaucoma drops
- Participation in other studies in the last 6 months
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04863742
Start Date
April 26 2021
End Date
September 30 2021
Last Update
April 28 2021
Active Locations (1)
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1
SightMD, LIASC
Brentwood, New York, United States, 11717