No Drop Post-Op Cataract Surgery

November 29, 2023 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Omidria
Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
Drug: Omidria
Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA) (Pre-op)
Time Frame: Baseline
Best vision will be tested with lens correction using Snellen Charts.
Baseline
Best Corrected Visual Acuity (BCVA) (Week 2)
Time Frame: 2 weeks
Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.
2 weeks
Best Corrected Visual Acuity (BCVA) (Week 6)
Time Frame: 6 weeks
Best distance vision will be measured clinically to determine if improvements have been made post-operatively.
6 weeks
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)
Time Frame: 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.
2 weeks
Change From Baseline in Macular Thickness Measurement - Number in Microns
Time Frame: 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
Baseline and week 6
Number of Participants Needing NSAID Post-operatively
Time Frame: 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.
Post-op weeks 1 through 6
Change in Anterior Chamber Cells From Baseline Measurement
Time Frame: 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
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Omeros Corporation

Investigators

  • Principal Investigator: Keith Walter, MD, Wake Forest Baptist Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00050415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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