Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

Cataract Clinical Trial

— ECPNTG  

Official title:

Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651530
• Other study ID #: 876543
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: December 1, 2026

Study information

• Verified date: December 2020
• Source: Helsinki University Central Hospital
• Contact: Nina M Lindbohm, MD, PhD
• Phone: +358505715668
• Email: nina.lindbohm[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• 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 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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma

Intervention

Procedure:
• Phaco
phacoemulsification of cataract only
• Phaco+ECP
Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract

Locations

Country	Name	City	State
Finland	Helsinki University 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	Succes rate	Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications	One year postoperatively
Secondary	Additional surgery	Comparison of the need for additional glaucoma surgery	Five years postoperatively