Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Normal Tension Glaucoma Clinical Trial

— DSTRENTG  

Official title:

Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371977
• Other study ID #: DSTRENTG
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: May 2029

Study information

• Verified date: March 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2029
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma

Intervention

Procedure:
• Trabeculectomy
trabeculectomy glaucoma surgery
• Deep Sclerectomy
deep sclerectomy glaucoma surgery

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications	One year
Secondary	Success Rate	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications	5 years