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

Last updated: November 26, 2024
Sponsor: Inder Paul Singh, M.D.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

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

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

Clinical Study ID

NCT06681688
MSS V2 6324
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 forthe 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 veinocclusion, history of epiretinal membrane, history of vitreomacular traction,evidence of posterior synechiae, etc.) MAY be enrolled provided there has been noevidence of active disease or treatment in the prior 12 months

  • Participants who do not meet the exclusion criteria may be enrolled.

Exclusion

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 thisinclude 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

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}
Phase: 1/2
Study Start date:
July 10, 2024
Estimated Completion Date:
August 31, 2025

Study 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).

Connect with a study center

  • The Eye Associates - Venice

    Venice, Florida 34292
    United States

    Active - Recruiting

  • The Eye Centers of Racine & Kenosha

    Racine, Wisconsin 53405
    United States

    Active - Recruiting

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