No Drop Post-Op Cataract Surgery

Wake Forest University (WFU)

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Drug: Omidria

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03864133

IRB00050415

Details and patient eligibility

About

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.

Full 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 results in an increase of the number of patients with macular edema and macular thickening.

Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery.

This study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.

Enrollment

94 patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

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.