Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL

Status unconfirmed · Phase 4

Conditions studied: Dry Eye Syndromes

In brief

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 eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.

Key facts

Study ID

NCT04863742

Run by

Sight Medical Doctors PLLC

People needed

30

Starts

2021-04-26

Expected to finish

2021-09-30

Last updated by the study team

2021-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SightMD, LIASC — Brentwood, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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