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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Best Corrected Visual Acuity (BCVA) (Pre-op)
Best vision will be tested with lens correction using Snellen Charts.
Time frame: Baseline
Best Corrected Visual Acuity (BCVA) (Week 2)
Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.
Time frame: 2 weeks
Best Corrected Visual Acuity (BCVA) (Week 6)
Best distance vision will be measured clinically to determine if improvements have been made post-operatively.
Time frame: 6 weeks
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)
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.
Time frame: 2 weeks
Change From Baseline in Macular Thickness Measurement - Number in Microns
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
Time frame: Baseline and week 6
Number of Participants Needing NSAID Post-operatively
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.
Time frame: Post-op weeks 1 through 6
Change in Anterior Chamber Cells From Baseline Measurement
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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
Time frame: Week 6