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Combined Pre-operative Treatment for Cataracts

Phase 1 & 2

Recruiting

Led By Paul Singh, MD

Research Sponsored by Inder Paul Singh, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants over 18 years of age undergoing bilateral cataract surgery

Be older than 18 years old

Must not have

Glaucoma patients or known steroid responders

Cataract surgery combined with any other procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying patients who need cataract surgery in both eyes. One eye will be in a group that receives the new treatment (Study Arm), and the other eye will be in a group

Who is the study for?

This trial is for patients scheduled for cataract surgery in both eyes. It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need to be adults with a diagnosis of cataracts and no other major eye diseases.

What is being tested?

The study compares complication rates between two treatments during cataract surgery. One eye gets NSAID, OMIDRIA, and triamcinolone (Study Arm), while the other eye receives standard care (Control Arm). The assignment of each treatment to an eye is random.

What are the potential side effects?

Possible side effects may include irritation at the injection site, increased pressure inside the eye, blurred vision, or allergic reactions. Specific side effects will depend on individual patient responses to the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and scheduled for cataract surgery in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have glaucoma or react strongly to steroids.

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I have had cataract surgery with another procedure.

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I have not had an eye injection in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

inflammation

Secondary study objectives

SPEED Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study Arm (OMIDRIA)Experimental Treatment1 Intervention

* 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).

Group II: Control Arm (Standard of Care)Active Control1 Intervention

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.

0 / 4Eligibility criteria met