Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

Not Applicable

Recruiting

• Conditions: Cataract; Normal Tension Glaucoma
• Interventions: Procedure: Phaco; Procedure: Phaco+ECP

• Registration Number: NCT04651530
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.

Detailed Description

Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Status Verified: 2020-12
• Study First Posted: 2020-12-03
• Study Start: 2020-12-08
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-22
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 stable with current medication assessed by a glaucoma specialist
• Clinically significant cataract

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
• Cataract due to eye injury or congenital cataract
• Zonular weakness due to Marfan syndrome or other
• 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 glaucoma progresses on current IOP
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phaco	Phaco	Cataract surgery only
Phaco+ECP	Phaco+ECP	Cataract surgery combined with endoscopic cyclophotocoagulation

Primary Outcome Measures

Name	Time	Method
Succes rate	One year postoperatively	Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications

Secondary Outcome Measures

Name	Time	Method
Additional surgery	Five years postoperatively	Comparison of the need for additional glaucoma surgery

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland