No Drop Post-Op Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT03864133|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2019
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Omidria||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
- Best Corrected Visual Acuity (BCVA) (pre-op) [ Time Frame: Baseline ]Best vision will be tested with lens correction using Snellen Charts.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Keith Walter, MD||Wake Forest Baptist Medical Center|