Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC
Purpose
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.
Condition
- Cataract
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. Exclusion Criteria: - Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.) - Glaucoma patients or known steroid responders - Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.) - Intraocular injection within 6 months - Any prior ocular implant - Diagnosis of retinal thickening in the study eye within 12 months of enrollment - Inability to provide informed consent - Participation in another clinical trial
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a 2-arm non-inferiority trial with the following arms: - Control arm: Participants undergoing cataract surgery using conventional standard of care peri-operative eyedrops. - Study arm: Participants undergoing cataract surgery with a regimen of peri-operative topical eyedrops administered to the participant by study staff, in combination with intracameral phenylephrine 1.0%/ketorolac 0.3%, subconjunctival triamcinolone acetonide, and intracameral moxifloxacin.
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
- Masking Description
- The biostatistician analyzing the data will be masked to both treatment arm and surgery center. When the Investigators or Sponsor look at the data, they will also be masked to treatment arm and surgery center.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Venice, Florida 34292
Racine, Wisconsin 53405
More Details
- NCT ID
- NCT06681688
- Status
- Recruiting
- Sponsor
- Inder Paul Singh, M.D.
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).