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Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma (SLT/OBF)

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Selective Laser Trabeculoplasty

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Selective Laser Trabeculoplasty, pulsatile ocular blood flow

Eligibility Criteria

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

Inclusion Criteria:

glaucoma patient
over 18 years
needs further intraocular pressure regulation

Exclusion Criteria:

age under 18 years
debilitated
no glaucoma

Sites / Locations

University Eye Clinic Dresden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

glaucoma patients

Arm Description

Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction

Outcomes

Primary Outcome Measures

Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)

Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)

Secondary Outcome Measures

Full Information

NCT ID

NCT01363362

First Posted

May 27, 2011

Last Updated

December 17, 2012

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT01363362

Brief Title

Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma

Acronym

SLT/OBF

Official Title

Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.

Detailed Description

Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Selective Laser Trabeculoplasty, pulsatile ocular blood flow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

glaucoma patients

Arm Type

Experimental

Arm Description

Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction

Intervention Type

Procedure

Intervention Name(s)

Selective Laser Trabeculoplasty

Other Intervention Name(s)

Lasertrabeculoplasty

Intervention Description

360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ

Primary Outcome Measure Information:

Title

Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)

Description

Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)

Time Frame

baseline and 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: glaucoma patient over 18 years needs further intraocular pressure regulation Exclusion Criteria: age under 18 years debilitated no glaucoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lutz E Pillunat, Prof. MD

Organizational Affiliation

University Eye Clinic Dresden

Official's Role

Study Chair

Facility Information:

Facility Name

University Eye Clinic Dresden

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma

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