Pre-Surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert And Effect On Intraocular Lens Measurement Accuracy

• Status: Not yet recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective study will use a self controlled design for 35 eyes. Patients scheduled to undergo routine cataract surgery in at least one of their eyes will have their pre-surgical measurements performed, IOL calculated and surgery planned. Then they will receive insertion of an intracanalicular dexamethasone insert into the inferior punctum. At 2 weeks (+/- 2 days) post-insertion, patients will return for an identical set of measurements. The IOL will be calculated and the surgery planned based on post-insert data. The insert will be removed if present (manually or via saline irrigation). This self controlled design allows for greater control of potential confounders tied to participants' systemic and ocular health.

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

Details

• Lead Sponsor: Prism Vision Group
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 18 years or older

• Visually significant cataract

• Dry eye disease

• BCVA potential of 20/40 or better

Exclusion Criteria:

• Pregnancy

• Concurrent use of topical glaucoma medications

• Corneal scarring

• History of LASIK or PRK

• History of rigid gas permeable (RGP) lens wear

• Macular or retinal pathology requiring intervention

• Cataract surgery complications