Status:
COMPLETED
No Drop Post-Op Cataract Surgery
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Omeros Corporation
Conditions:
Cataract
Eligibility:
All Genders
55-90 years
Phase:
PHASE4
Brief 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/Ketorol...
Detailed Description
Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03864133
Start Date
July 8 2019
End Date
August 16 2021
Last Update
November 30 2023
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157