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Recruiting NCT04651530

Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

No phase Interventional Normal Tension Glaucoma Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phaco, Phaco+ECP.
Who it may be relevant to
Registry conditions: Normal Tension Glaucoma, Cataract. Basic parameters: 55 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Succes rate [Time frame: One year postoperatively]
Secondary outcome measures (1)
  • Additional surgery [Time frame: Five years postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Helsinki University Hospital — Helsinki

Identifiers

NCT: NCT04651530 · 876543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗