A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery

Part of paid clinical trials in Garden City, New York.

Sponsor
Ophthalmic Consultants of Long Island
Study ID
NCT04205916
Phase
PHASE4
Status
Recruiting
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Conditions

  • Patient Preference

Eligibility Criteria

Sex
ALL
Age
22 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Dexamethasone — DRUG
    Drugs to be administer during cataract surgery to experimental group
  • Standard of care surgery — OTHER
    Standard method used for surgery and the use of post operative drops

Study Details

To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.

Key Dates

Start date
Nov 4, 2019
Status verified
Dec 2019
Primary completion
Jun 30, 2020
Completion
Dec 1, 2020

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Experimental Group
    A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure.
  • Active Comparator: Control Group
    A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.

Primary Outcome Measure

Patient Preference [ Time Frame: Day 28 of second eye surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ophthalmic Consultants of Long IslandGarden CityNew York11530
Erin Loweree
[email protected]
516-593-4026
Isabel Lezcano
[email protected]
516-593-4026
Eric Donnenfeld (PRINCIPAL_INVESTIGATOR)

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Ophthalmic Consultants of Long Island· Garden City, NY

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