Wake Forest University Health Sciences is holding a clinical trial on infusions of Phenylephrine/Ketorolac during surgery for Retinal Thickness and Macular Edema in Cataract Surgery instead of topical NSAID drops. Omidria during cataract surgery will be used in place of NSAIDs.
There is an estimated enrollment of 200 participants. Best Corrected Visual Acuity will be assessed before the operation, 2 weeks and 6 weeks after the operation. Development of the presence of cystoid macular edema will be assessed 2 weeks after the operation. A macular thickness measurement will be taken 2 weeks and 6 weeks after the operation. The amount of topical NSAID needed will be assessed in weeks 1 through 6 after the operation. A change in interior chamber cell and flare will be assessed 1 day, week 2, and week 6 after the operation.
All sexes, ages 55 to 90 years old are allowed to participate. Those not allowed to participate include:
- Those with visually 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.
Those not allowed to participate include:
- Those with an 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 fragments post-operatively.
- Inability to return for follow-up appointments
- Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.
Those interested may participate in this study at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, 27157. Feel free to contact Blair Gordy at 336-716-3937 with any questions or concerns.
This clinical trial is sponsored by the Wake Forest University Health Sciences and collaborated by Omeros Corporation. Keith Walter, MD is the Principal Investigator.
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