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

November 26, 2024 updated by: Inder Paul Singh, M.D.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Venice, Florida, United States, 34292
        • Recruiting
        • The Eye Associates - Venice
        • Contact:
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • The Eye Centers of Racine & Kenosha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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).
Other Names:
  • (OMIDRIA), Phenylephrine (1%) and Ketorolac (0.3%) intraocular solution
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.
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%)
Other Names:
  • TORADOL (Generic), Vigamox, Avalox, Pred Forte, Prelone, Omnipred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation
Time Frame: 8 days
The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score}
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPEED Questionnaire
Time Frame: 30 days
Mean change in SPEED Questionnaire from baseline to Day 8 and baseline to Day 30
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inder Paul Singh, M.D.

Collaborators

The Eye Associates

Investigators

  • Principal Investigator: Paul Singh, MD, The Eye Centers of Racine & Kenosha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSS V2 6324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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