Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to compare the maintenance of intraoperative mydriasis during cataract surgery between two drugs: epinephrine, which has routinely been used for decades, and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients undergoing cataract surgery that are enrolled in the trial will randomly receive one of the drugs in one eye, and the other eye will receive the drug during the subsequent cataract surgery.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02895035
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Enrolling by invitation
Phase Phase 4
Start date September 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT02529488 - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 N/A
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT02888210 - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery Phase 3
Completed NCT03356847 - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery N/A
Recruiting NCT03638726 - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification Phase 4
Terminated NCT03145116 - Clinical Safety and Efficacy of CT ASPHINA 509 Lenses N/A
Completed NCT02842151 - Optimizing the Assessment of Refractive Outcomes After Cataract Surgery N/A
Not yet recruiting NCT03593616 - Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery
Not yet recruiting NCT02780063 - Medications Effect on Lenstar Measurements N/A
Completed NCT03224728 - Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses N/A
Completed NCT02698943 - Glistenings and PCO Evaluation for the Envista MX60 N/A
Completed NCT02867189 - Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety N/A
Active, not recruiting NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02633072 - Visual Acuity After the Combined Binocular Implantation of +2.75 Diopters and +3.25 Diopters Tecnis Multifocal Intraocular Lenses. Phase 4
Completed NCT03206983 - Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases N/A
Completed NCT02208297 - Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery Phase 3
Completed NCT02235272 - Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation Phase 3
Enrolling by invitation NCT01654159 - Assessment of Visual Function and Optics in Intraocular Lenses N/A
Completed NCT01938989 - Effect of Blue Light Filtration on Visual Performance N/A
Completed NCT02089698 - Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification Phase 4