Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

Helsinki University Central Hospital100 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Normal Tension Glaucoma Cataract

Interventions

PhacoPROCEDURE

phacoemulsification of cataract only

Phaco+ECPPROCEDURE

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Outcomes

Primary Outcomes

Succes rate

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

Time frame: One year postoperatively

Secondary Outcomes

Additional surgery

Comparison of the need for additional glaucoma surgery

Time frame: Five years postoperatively

Central Contacts

Nina M Lindbohm, MD, PhD

CONTACT

+358505715668 nina.lindbohm@hus.fi

Data from ClinicalTrials.gov

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