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Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma (ECPNTG)

Primary Purpose

Normal Tension Glaucoma, Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Phaco
Phaco+ECP
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring endoscopic cyclophotocoagulation, ECP, Surgery

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Phaco

Phaco+ECP

Arm Description

Cataract surgery only

Cataract surgery combined with endoscopic cyclophotocoagulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Additional surgery
Comparison of the need for additional glaucoma surgery

Full Information

First Posted
November 26, 2020
Last Updated
December 18, 2020
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04651530
Brief Title
Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
Acronym
ECPNTG
Official Title
Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma, Cataract
Keywords
endoscopic cyclophotocoagulation, ECP, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phaco
Arm Type
Active Comparator
Arm Description
Cataract surgery only
Arm Title
Phaco+ECP
Arm Type
Experimental
Arm Description
Cataract surgery combined with endoscopic cyclophotocoagulation
Intervention Type
Procedure
Intervention Name(s)
Phaco
Intervention Description
phacoemulsification of cataract only
Intervention Type
Procedure
Intervention Name(s)
Phaco+ECP
Intervention Description
Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract
Primary Outcome Measure Information:
Title
Succes rate
Description
Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications
Time Frame
One year postoperatively
Secondary Outcome Measure Information:
Title
Additional surgery
Description
Comparison of the need for additional glaucoma surgery
Time Frame
Five years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina M Lindbohm, MD, PhD
Phone
+358505715668
Email
nina.lindbohm@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Harju, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jukka AO Moilanen, MD, PhD
Phone
+358405820860
Email
jukka.moilanen@hus.fi

12. IPD Sharing Statement

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Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma

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