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

Sight Medical Doctors PLLC

Status and phase: Unknown; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04863742

ENHANCE

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
3. Ability to provide informed consent for procedures
4. Ability to attend scheduled follow up visits
5. No other corneal pathology to create unknown variability

Exclusion criteria

1. Age less than 18
2. Pregnancy/currently breast-feeding
3. Inability to provide informed consent
4. Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
5. Punctal stenosis
6. Previous corneal transplant surgery or refractive surgery
7. Concurrent use of topical steroid eye drops
8. Systemic, topical or intravitreal steroid use within 1 month of baseline
9. Active history of chronic or recurrent inflammatory eye disease in either eye
10. History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
11. History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
12. Diagnosis of Glaucoma or use of topical glaucoma drops
13. Participation in other studies in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dextenza Arm

Experimental group

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Prednisolone Acetate 1%

Active Comparator group

Treatment:

Drug: Prednisolone Acetate