Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma (DSTRENTG)

The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Normal Tension Glaucoma
• Intervention / Treatment: Procedure: Trabeculectomy; Procedure: Deep Sclerectomy

Detailed Description

Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00990
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Nina Lindbohm, MD, PhD; Phone Number: +358 9 4711; Email: nina.lindbohm@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed Informed Consent
• Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
• Glaucoma unstable with current medication assessed by a glaucoma specialist

Exclusion Criteria:

• Secondary Glaucoma e.g. due to previous injury or uveitis
• Exfoliation syndrome
• Pigment dispersion syndrome
• Previous transscleral or endoscopic cyclophotocoagulation
• Previous other glaucoma surgery
• Previous retinal detachment
• Previous intraocular surgery like vitrectomy and other retinal surgery
• Wet age-related macular degeneration
• Diabetic retonopathy
• Previous corneal transplant or previous refractive surgery
• Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
• The patient does not want to participate in the study
• The patient does not speak Finnish, Swedish or English
• Dementia
• Only eye with vision worse than 20/200 or loss of central visual field

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trabeculectomy	Procedure: Trabeculectomy; trabeculectomy glaucoma surgery
Experimental: Deep sclerectomy	Procedure: Deep Sclerectomy; deep sclerectomy glaucoma surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications	5 years

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Low Tension Glaucoma
• Other Study ID Numbers: DSTRENTG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No