NCT06681688

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Inder Paul Singh, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For the control arm interventions: Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. 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, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate Eyes in the Control Arm 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. For the study arm interventions: Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate. Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide. The following study assessments will take place for all subjects: Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity \[VA\] or best corrected visual acuity \[BCVA\]) * Slit lamp examination, including intraocular pressure (IOP) measurement * Grading of inflammation * Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire * Pain assessment on a 0-4 scale * Overall participant satisfaction on a 0-10 scale * Optical coherence tomography (OCT) imaging Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate. Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).

Conditions

• Cataract

Interventions

Type	Name	Description
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%)

Timeline

• Start date: 2024-07-10
• Primary completion: 2025-06-01
• Completion: 2025-08-01
• First posted: 2024-11-08
• Last updated: 2024-11-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study