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Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

NCT ID: NCT04651530

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Normal Tension Glaucoma Cataract

Keywords

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endoscopic cyclophotocoagulation ECP Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phaco

Cataract surgery only

Group Type ACTIVE_COMPARATOR

Phaco

Intervention Type PROCEDURE

phacoemulsification of cataract only

Phaco+ECP

Cataract surgery combined with endoscopic cyclophotocoagulation

Group Type EXPERIMENTAL

Phaco+ECP

Intervention Type PROCEDURE

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

Interventions

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Phaco

phacoemulsification of cataract only

Intervention Type PROCEDURE

Phaco+ECP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Mika Harju

Head of Glaucoma department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mika Harju, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Nina M Lindbohm, MD, PhD

Role: CONTACT

Phone: +358505715668

Email: [email protected]

Facility Contacts

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Jukka AO Moilanen, MD, PhD

Role: primary

Other Identifiers

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876543

Identifier Type: -

Identifier Source: org_study_id