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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sight Medical Doctors PLLC
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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