Pilocarpine Use After Kahook Goniotomy

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT03933631
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pilocarpine — DRUG
    pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)
  • Prednisolone — DRUG
    Prednisolone acetate ophthalmic suspension 1%
  • Ofloxacin — DRUG
    Ofloxacin Drops

Study Details

The goal of this study is to determine whether using pilocarpine provides added benefit to the success of combined cataract + Kahook Dual Blade (KDB) surgery.

Key Dates

Start date
May 1, 2019
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pilocarpine, Prednisolone acetate and Ofloxacin
    This group will use 2% pilocarpine in the postoperative period, for one month, in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
  • Active Comparator: Prednisolone acetate and Ofloxacin (standard of care)
    This group will use only the standard Prednisolone acetate and Ofloxacin, without pilocarpine.

Primary Outcome Measure

Percentage of patients with lowering of intraocular pressure (IOP) [ Time Frame: From baseline to 1 year following procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Wen-Jeng (Melissa) Yao, MD
Wen-Jeng (Melissa) Yao, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Wakefield CampusThe BronxNew York10466-

Find similar trials in The Bronx, NY

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Montefiore Medical Center· The Bronx, NYMontefiore Wakefield Campus· The Bronx, NY

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