No Drop Post-Op Cataract Surgery

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03864133
Collaborator
Omeros Corporation (Industry)
100
Enrollment
1
Location
1
Arm
25.3
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery
Actual Study Start Date :
Jul 8, 2019
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Aug 16, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Visual Acuity (BCVA) (pre-op) [Baseline]

    Best vision will be tested with lens correction using Snellen Charts.

  2. 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.

  3. 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.

  4. 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.

  5. Change From Baseline in Macular Thickness Measurement [Baseline, 2 weeks and 6 weeks]

    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.

  6. Amount of Topical NSAID needed [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.

  7. Change in Anterior Chamber cell and flare from baseline measurement [Post-op day 1, week 2 and week 6]

    Anterior chamber cells and flare will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wake Forest Baptist Medical CenterWinston-SalemNorth CarolinaUnited States27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • Omeros Corporation

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03864133
Other Study ID Numbers:
  • IRB00050415
First Posted:
Mar 6, 2019
Last Update Posted:
Oct 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021