Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma (DSTRENTG)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Normal Tension Glaucoma

Treatments: Procedure: Trabeculectomy; Procedure: Deep Sclerectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05371977

DSTRENTG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Deep sclerectomy

Experimental group

Treatment:

Procedure: Deep Sclerectomy

Trabeculectomy

Active Comparator group

Treatment:

Procedure: Trabeculectomy