No Drop Post-Op Cataract Surgery



Status:Not yet recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - 90
Updated:3/8/2019
Start Date:March 2019
End Date:December 2020
Contact:Blair Gordy
Email:bgordy@wakehealth.edu
Phone:336-716-3937

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The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery

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.

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.

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.
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Phone: 336-716-3937
?
mi
from
Winston-Salem, NC
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