NCT01886456

Brief Summary

To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension. Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.

  • Trial with medical device

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

4 years

First QC Date

June 21, 2013

Last Update Submit

June 24, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure 6 months after Intervention

    6 months

Study Arms (2)

PLT

EXPERIMENTAL

patients treated with patterned laser trabeculoplasty

Device: Laser trabeculoplasty

SLT

ACTIVE COMPARATOR

patients treated with selective laser trabeculoplasty

Device: Laser trabeculoplasty

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \> 21 mm Hg
  • visible angle structures over 360° on gonioscopy
  • age = 18 years

You may not qualify if:

  • Intraocular Inflammation
  • patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
  • monocle situation
  • anterior chamber lenses (incl. iris claw)
  • secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Ophthalmology Clinic

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

  • Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Christoph Kniestedt, MD

    University Hospital Zurich, Ophthalmology Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregor Jaggi, MD

CONTACT

Christoph Kniestedt, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations