Trabeculectomy Versus 2-iStent and Prostaglandin Study

NCT03274323 | Withdrawn DMC FDA Device

• 1 other identifier: IRB00146334
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (3)

• IOP <= 18 mmHg

  IOP

  Post surgery month 4

• IOP <= 15 mmHg

  IOP

  Post surgery month 4

• IOP >= 20% reduction from untreated baseline

  IOP

  Post surgery month 4

Study Arms (2)

2 iStent with travoprost or latanoprost

EXPERIMENTAL

2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery

Device: iStent and travoprost or latanoprost

trabeculectomy

ACTIVE COMPARATOR

Standard trabeculectomy

Procedure: Trabeculectomy

Interventions

iStent and travoprost or latanoprost DEVICE

2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure

2 iStent with travoprost or latanoprost

Trabeculectomy PROCEDURE

Standard trabeculectomy

trabeculectomy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 6, 2017
• Study Start: January 12, 2018
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share