No Drop Post-Op Cataract Surgery

• Status: Completed
• Trial end date: 2021-08-16
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: Omeros Corporation
• Treatments: Ketorolac; Ketorolac Tromethamine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Adults age 55-90 years with visual significant cataracts in one or both eyes.

• Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.

• Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.

Exclusion Criteria:

• Allergy to Phenylephrine or NSAIDs.

• Inability to sit steady and upright for the Optical Coherence Tomography (OCT).

• Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.

• Macular thickness above 300 microns at baseline

• Currently taking a prostaglandin analogue

• Presence of an epiretinal membrane on the preoperative OCT.

• Retained lens fragment post-operatively.

• Inability to return for follow appointments

• Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.