Prospective Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative Standard of Care
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult participants \> 18 years of age undergoing bilateral cataract surgery
• Able to provide written informed consent prior to any study related procedure
• Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
• Patients deemed to be higher risk for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
• Participants who do not meet the exclusion criteria may be enrolled.
Locations
United States
Florida
The Eye Associates - Venice
RECRUITING
Venice
Wisconsin
The Eye Centers of Racine & Kenosha
RECRUITING
Racine
Contact Information
Primary
Paul Singh, MD
ipsingh@amazingeye.com
262-637-0500
Backup
Cathleen McCabe, MD
mccabe131@hotmail.com
941-493-3763
Time Frame
Start Date:2024-07-10
Estimated Completion Date:2025-08
Participants
Target number of participants:94
Treatments
Experimental: Study Arm (OMIDRIA)
* Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox}~* Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)~* Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte}~* Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).~Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}.~In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).~Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician).
Active_comparator: Control Arm (Standard of Care)
Self-administration of:~Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX.~On the Day of SX, eyes will receive in-office drops administered by study staff according to the following:~* In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)~* Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)~* At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte}~* Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).~Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.