NCT01363362

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

May 27, 2011

Last Update Submit

December 17, 2012

Conditions

Glaucoma

Keywords

Selective Laser Trabeculoplastypulsatile ocular blood flow

Outcome Measures

Primary Outcomes (1)

  • 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.)

    baseline and 3 month

Study Arms (1)

glaucoma patients

EXPERIMENTAL

Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction

Procedure: Selective Laser Trabeculoplasty

Interventions

Selective Laser TrabeculoplastyPROCEDURE

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

Also known as: Lasertrabeculoplasty
glaucoma patients

Eligibility Criteria

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

You may qualify if:

  • glaucoma patient
  • over 18 years
  • needs further intraocular pressure regulation

You may not qualify if:

  • age under 18 years
  • debilitated
  • no glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Lutz E Pillunat, Prof. MD

    University Eye Clinic Dresden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 1, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

DE(1)