ECPNTG: Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04651530
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 71.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Tension Glaucoma; Cataract	Procedure: Phaco; Procedure: Phaco+ECP	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
• Actual Study Start Date: Dec 8, 2020
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phaco Cataract surgery only	Procedure: Phaco; phacoemulsification of cataract only
Experimental: Phaco+ECP Cataract surgery combined with endoscopic cyclophotocoagulation	Procedure: Phaco+ECP; Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract

Outcome Measures

Primary Outcome Measures

1. Succes rate [One year postoperatively]

   Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications

Secondary Outcome Measures

1. Additional surgery [Five years postoperatively]

   Comparison of the need for additional glaucoma surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland	00029

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

• Principal Investigator: Mika Harju, MD, PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Mika Harju, Head of Glaucoma department, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT04651530
• Other Study ID Numbers: 876543
• First Posted: Dec 3, 2020
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Mika Harju, Head of Glaucoma department, Helsinki University Central Hospital: endoscopic cyclophotocoagulation; ECP; Surgery
• Additional relevant MeSH terms: Glaucoma; Cataract; Low Tension Glaucoma

Study Results

No Results Posted as of Dec 22, 2020