Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size
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|ClinicalTrials.gov Identifier: NCT02895035|
Recruitment Status : Terminated (Data analysis was never performed by sub-investigator)
First Posted : September 9, 2016
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Phenylephrine-ketorolac Drug: Epinephrine||Phase 4|
Cataract remains a leading cause of correctable blindness worldwide. Over 3.5 million cataract surgeries in the United States and 20 million cataract surgeries worldwide are performed every year. Cataract surgery is performed by making a small incision, removing the cataractous lens, most often through the process of phacoemulsification, and replacement with an intraocular lens. Like all surgeries, adequate exposure and field of view is vital for a safe and effective surgery. In cataract surgery, the field of view is limited by the diameter of the pupil. Several different drugs, such as cyclopentolate, tropicamide, phenylephrine, and epinephrine are utilized to maintain dilation (mydriasis) of the pupil during surgery.
There are currently two prospective randomized controlled trials comparing phenylephrine/ketorolac to placebo in the published literature. Both of these studies demonstrated that phenylephrine/ketorolac is superior to placebo for the maintenance of mydriasis during cataract surgery. Epinephrine has been the standard of care for intraoperative mydriasis. Phenylephrine/ketorolac (Omidria) is a newly FDA-approved additive for the maintenance of intraoperative mydriasis, but there are currently no published studies comparing epinephrine to phenylephrine/ketorolac for maintenance of mydriasis during cataract surgery.
While both of these drugs have been shown to be superior to placebo for the maintenance of mydriasis, there is a significant cost difference between epinephrine, which has been used for many years, and phenylephrine/ketorolac, which gained FDA approval in 2014. One 4 mL vial of Omidria® is utilized for one cataract surgery, which costs $465.
The primary endpoint to be measured in the study is the mean area under the curve change from baseline in pupil diameter over time to the end of cataract surgery.
Secondary endpoints will be maximum intraoperative pupil constriction, subjects with pupil diameter less than 6.5 mm at any during surgery, subjects with pupil less than 6.0 mm during cortical clean-up, and subjects with greater than 2.5 mm of pupillary constriction at any time during surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Comparison of Epinephrine and Phenylephrine/Ketorolac (Omidria®) Additives With Regards to Intraoperative Pupil Size|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Active Comparator: Epinephrine
Epinephrine is the intracameral additive during cataract surgery.
Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
Active Comparator: Omidria
Omidria is the intracameral additive during cataract surgery.
Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
Other Name: Omidria
- the mean area under the curve change from baseline in pupil diameter over time to the end of cataract surgery [ Time Frame: N/A (during cataract surgery) ]
- maximum intraoperative pupil constriction [ Time Frame: N/A (during cataract surgery) ]
- percentage of subjects with pupil diameter less than 6.5 mm at any during surgery [ Time Frame: N/A (during cataract surgery) ]
- percentage of subjects with pupil less than 6.0 mm during cortical clean-up [ Time Frame: N/A (during cataract surgery) ]
- percentage of subjects with greater than 2.5 mm of pupillary constriction at any time during surgery [ Time Frame: N/A (during cataract surgery) ]