DSTRENTG: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05371977
• Collaborator: (none)
• Enrollment: 80
• Arm: 1
• Anticipated Duration (Months): 84

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Tension Glaucoma	Procedure: Trabeculectomy; Procedure: Deep Sclerectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glaucoma patient	Procedure: Trabeculectomy; trabeculectomy glaucoma surgery; Procedure: Deep Sclerectomy; deep sclerectomy glaucoma surgery

Outcome Measures

Primary Outcome Measures

1. Success Rate [One year]

   Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Secondary Outcome Measures

1. Success Rate [5 years]

   Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nina Lindbohm, Principal Investigator, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT05371977
• Other Study ID Numbers: DSTRENTG
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Low Tension Glaucoma

Study Results

No Results Posted as of May 12, 2022