NCT04863742

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

Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sight Medical Doctors PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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%.

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 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%. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, a total of 30 patients will be randomized into two groups: Group 1: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive a 0.4mg dexamethasone intracanalicular insert at the days of each surgery. Group 2: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive prednisolone acetate 1% QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen starting at the days of each surgery. All patient eyes will receive Prolensa 0.07% ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 0.6% eye drops TID/starting 3 days prior to surgery. Per enrolled eye, the study period will last for approximately 30 days after surgery, consisting of three postop follow-up visits (six total postop visits per patient). At Day 1, Day 7 and Day 30, primary and secondary endpoints will be assessed alongside standard-of-care procedures. SPEED questionnaire will be assessed by a masked survey administrator. Adjusting for enrollment period, the study will last a total of approximately 12 months, including submission for publication/ presentation.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	sustained released dexamethasone, 0.4mg
DRUG	Prednisolone Acetate	Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-07-31
• Completion: 2021-09-30
• First posted: 2021-04-28
• Last updated: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study