The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity (SLT/ORA)

February 6, 2017 updated by: Dr. Karin Pillunat, Technische Universität Dresden
The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ.

The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • University Eye Clinic Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma

Exclusion Criteria:

other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: glaucoma patients
All of the patients treated with SLT need further IOP reduction for control of their glaucoma.
Procedure: Selective Laser Trabeculoplasty
100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.
Other Names:
  • SLT
  • ORA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in ocular rigidity
Time Frame: 4 weeks
Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP reduction
Time Frame: 4 weeks
Is there an effective IOP drop after SLT?
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Karin R Hornykewycz, MD, University Eye Clinic Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLT/ORA/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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