NCT04651530

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Dec 2020Dec 2026

First Submitted

Initial submission to the registry

November 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

5 years

First QC Date

November 26, 2020

Last Update Submit

December 18, 2020

Conditions

Normal Tension GlaucomaCataract

Keywords

endoscopic cyclophotocoagulationECPSurgery

Outcome Measures

Primary Outcomes (1)

  • Succes rate

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

    One year postoperatively

Secondary Outcomes (1)

  • Additional surgery

    Five years postoperatively

Study Arms (2)

Phaco

ACTIVE COMPARATOR

Cataract surgery only

Procedure: Phaco

Phaco+ECP

EXPERIMENTAL

Cataract surgery combined with endoscopic cyclophotocoagulation

Procedure: Phaco+ECP

Interventions

PhacoPROCEDURE

phacoemulsification of cataract only

Phaco
Phaco+ECPPROCEDURE

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

Phaco+ECP

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Low Tension GlaucomaCataract

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve DiseasesLens Diseases

Study Officials

  • Mika Harju, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina M Lindbohm, MD, PhD

CONTACT

+358505715668nina.lindbohm@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Glaucoma department

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 3, 2020

Study Start

December 8, 2020

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

FI(1)