Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma (ECPNTG)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Cataract; Normal Tension Glaucoma

Treatments: Procedure: Phaco+ECP; Procedure: Phaco

Study type: Interventional

Funder types: Other

Identifiers

NCT04651530

876543

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Phaco

Active Comparator group

Description:

Cataract surgery only

Treatment:

Procedure: Phaco

Phaco+ECP

Experimental group

Description:

Cataract surgery combined with endoscopic cyclophotocoagulation

Treatment:

Procedure: Phaco+ECP