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No Drop Post-Op Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864133
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
Omeros Corporation
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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 disease Intervention/treatment Phase
Cataract Drug: Omidria 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
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Study Type : Interventional  (Clinical Trial)
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 : July 8, 2019
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : August 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) (pre-op) [ Time Frame: Baseline ]
    Best vision will be tested with lens correction using Snellen Charts.

  2. 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.

  3. 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.

  4. 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.

  5. Change From Baseline in Macular Thickness Measurement [ Time Frame: 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 [ 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.

  7. Change in Anterior Chamber cell and flare from baseline measurement [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864133


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Omeros Corporation
Investigators
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Principal Investigator: Keith Walter, MD Wake Forest Baptist Medical Center
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] December 14, 2020

More Information
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Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03864133    
Other Study ID Numbers: IRB00050415
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cataract
Lens Diseases
Eye Diseases