Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04651530

Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00029, Finland

Location status: Recruiting

Location contact

Jukka AO Moilanen, MD, PhD

CONTACT

[email protected]

+358405820860

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phaco

Procedure

phacoemulsification of cataract only

Phaco+ECP

Procedure

Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract

Primary outcomes

  1. Succes rate

    Time frame: One year postoperatively

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

Secondary outcomes

  1. Additional surgery

    Time frame: Five years postoperatively

    Comparison of the need for additional glaucoma surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Nina M Lindbohm, MD, PhD

CONTACT

[email protected]

+358505715668

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: ECPNTG

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.