Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Cataract
Interventions
DRUG

Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}

Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).

DRUG

Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}

"On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:~* In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)~* Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)~* At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)~* Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)"

Trial Locations (2)

34292

RECRUITING

The Eye Associates - Venice, Venice

53405

RECRUITING

The Eye Centers of Racine & Kenosha, Racine

All Listed Sponsors
collaborator

The Eye Associates

OTHER

lead

Inder Paul Singh, M.D.

OTHER