Status:

WITHDRAWN

Trabeculectomy Versus 2-iStent and Prostaglandin Study

Lead Sponsor:

Johns Hopkins University

Conditions:

Glaucoma, Open-Angle

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to incre...

Detailed Description

This will be a prospective randomized controlled study. 20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be...

Eligibility Criteria

Inclusion

  • Patients who have mental capacity to give consent
  • Age \>= 21 years
  • Pseudophakic or phakic without visually significant cataract
  • Open angle glaucoma
  • IOP in the range of 18-30 mmHg with 2 or more topical medications
  • Cup-disc ratio =\< 0.9
  • Best corrected visual acuity of 20/100 or better

Exclusion

  • Inability to give consent
  • Inability to tolerate or presence of allergy to prostaglandin analogs
  • Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
  • Age \< 21 years
  • Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
  • Secondary glaucoma or angle closure glaucoma
  • Aphakia
  • Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)
  • Prior laser trabeculoplasty \< 90 days prior to screening or absolute failure of prior laser trabeculoplasty.

Key Trial Info

Start Date :

January 12 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 12 2018

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03274323

Start Date

January 12 2018

End Date

January 12 2018

Last Update

January 19 2018

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