No Drop Post-Op Cataract Surgery

Phase 4

Completed

• Conditions: Cataract
• Interventions: Drug: Omidria

• Registration Number: NCT03864133
• Lead Sponsor: Wake Forest University Health Sciences

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/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.

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 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.

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Study Start: 2019-07-08
• Status Verified: 2021-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-16
• Results First Submitted: 2023-10-12
• Results First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Results First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omidria	Omidria	Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Macular Thickness Measurement - Number in Microns	Baseline and week 6	The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns
Best Corrected Visual Acuity (BCVA) (Pre-op)	Baseline	Best vision will be tested with lens correction using Snellen Charts.
Best Corrected Visual Acuity (BCVA) (Week 2)	2 weeks	Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.
Best Corrected Visual Acuity (BCVA) (Week 6)	6 weeks	Best distance vision will be measured clinically to determine if improvements have been made post-operatively.
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)	2 weeks	The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically.
Number of Participants Needing NSAID Post-operatively	Post-op weeks 1 through 6	Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.
Change in Anterior Chamber Cells From Baseline Measurement	Week 6	Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.; Range and meaning (if score/scale): 0-2 0 = no cell; 1. = 10-20 cells; 2. = greater than 20 cells

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States