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Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy (SLT)

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension, Cataract

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Selective Laser Trabeculoplasty
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open angle glaucoma, Ocular hypertension, Cataract, Selective Laser Trabeculoplasty, Eximer Laser Trabeculectomy, Phacoemulsification Cataract Extraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLT arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy intraocular pressure
Efficacy as measured by decrease in intraocular pressure from baseline
Efficacy medication
as measured by decrease in number of used hypotensive medications

Secondary Outcome Measures

Efficacy visual acuity
Efficacy as increase in best corrected visual acuity

Full Information

First Posted
January 29, 2015
Last Updated
June 19, 2017
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02434250
Brief Title
Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy
Acronym
SLT
Official Title
Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

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

5. Study Description

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.
Detailed Description
This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension, Cataract
Keywords
Open angle glaucoma, Ocular hypertension, Cataract, Selective Laser Trabeculoplasty, Eximer Laser Trabeculectomy, Phacoemulsification Cataract Extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLT arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Selective Laser Trabeculoplasty
Intervention Description
Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.
Primary Outcome Measure Information:
Title
Efficacy intraocular pressure
Description
Efficacy as measured by decrease in intraocular pressure from baseline
Time Frame
t0 and t=12 month
Title
Efficacy medication
Description
as measured by decrease in number of used hypotensive medications
Time Frame
t0 and t=12 month
Secondary Outcome Measure Information:
Title
Efficacy visual acuity
Description
Efficacy as increase in best corrected visual acuity
Time Frame
t0 and t=12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of open angle glaucoma or ocular hypertension and diagnosis of cataract Exclusion Criteria: diagnosis of angle closure glaucoma any optic neuropathy other than glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Toeteberg-Harms, MD, FEBO
Organizational Affiliation
UniversityHospital Zurich, Dept. of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy

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