Trabeculectomy Versus 2-iStent and Prostaglandin Study

Glaucoma, Open-Angle Clinical Trial

— TIPS  

Official title:

Trabeculectomy Versus 2-iStent and Prostaglandin Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03274323
• Other study ID #: IRB00146334
• Status: Withdrawn
• Phase: N/A
• First received: September 5, 2017
• Last updated: January 17, 2018
• Start date: January 12, 2018
• Est. completion date: January 12, 2018

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle

Intervention

Device:
• iStent and travoprost or latanoprost
2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure

Procedure:
• Trabeculectomy
Standard trabeculectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP <= 18 mmHg	IOP	Post surgery month 4
Primary	IOP <= 15 mmHg	IOP	Post surgery month 4
Primary	IOP >= 20% reduction from untreated baseline	IOP	Post surgery month 4