Trabeculectomy Versus 2-iStent and Prostaglandin Study (TIPS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: iStent and travoprost or latanoprost; Procedure: Trabeculectomy

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 randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2 iStent with travoprost or latanoprost; 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; 2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
ACTIVE_COMPARATOR: trabeculectomy; Standard trabeculectomy	Procedure: Trabeculectomy; Standard trabeculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2018
• Primary Completion (ACTUAL): January 12, 2018
• Study Completion (ACTUAL): January 12, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (ACTUAL): September 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: IRB00146334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes