NCT02434250

Brief Summary

The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

January 29, 2015

Last Update Submit

June 19, 2017

Conditions

Open Angle GlaucomaOcular HypertensionCataract

Keywords

Open angle glaucomaOcular hypertensionCataractSelective Laser TrabeculoplastyEximer Laser TrabeculectomyPhacoemulsification Cataract Extraction

Outcome Measures

Primary Outcomes (2)

  • Efficacy intraocular pressure

    Efficacy as measured by decrease in intraocular pressure from baseline

    t0 and t=12 month

  • Efficacy medication

    as measured by decrease in number of used hypotensive medications

    t0 and t=12 month

Secondary Outcomes (1)

  • Efficacy visual acuity

    t0 and t=12 month

Study Arms (1)

SLT arm

EXPERIMENTAL

Patient receiving 'Selective Laser Trabeculoplasty' (SLT) due to failed Phacoemulsification Cataract Extraction with Intraocular Lens Implantation combined with Eximer Laser Trabeculectomy (phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension to control intraocular pressure and/or glaucoma progression.

Procedure: Selective Laser Trabeculoplasty

Interventions

Selective Laser TrabeculoplastyPROCEDURE

Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.

SLT arm

Eligibility Criteria

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

You may qualify if:

  • diagnosis of open angle glaucoma or ocular hypertension
  • and diagnosis of cataract

You may not qualify if:

  • diagnosis of angle closure glaucoma
  • any optic neuropathy other than glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionCataract

Condition Hierarchy (Ancestors)

GlaucomaEye DiseasesLens Diseases

Study Officials

  • Marc Toeteberg-Harms, MD, FEBO

    UniversityHospital Zurich, Dept. of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

May 5, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)