Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

Silverstein Eye Centers15 enrolled

Overview

This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Surgery

Interventions

OmidriaDRUG

phenylephrine 1% and ketorolac 0.3% intraocular solution

Dextenza (dexamethasone ophthalmic insert) 0.4mgDRUG

intracanalicular dexamethasone insert

Dexycu, 9% Intraocular SuspensionDRUG

dexamethasone intraocular suspension

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery. Exclusion Criteria: * Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.

Locations (1)

Silverstein Eye Centers

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Resolution of anterior chamber inflammation

The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.

Time frame: Assessed at day 8 post-operatively

Resolution of anterior chamber inflammation

Time frame: Assessed at day 15 post-operatively

Resolution of anterior chamber inflammation

Time frame: Assessed at day 30 post-operatively

Secondary Outcomes

Resolution of postoperative pain

The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).

Time frame: Assessed at day 1 post-operatively

Resolution of postoperative pain

The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).

Time frame: Assessed at day 8 post-operatively

Data from ClinicalTrials.gov

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