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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Selective Laser Trabeculoplasty
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, selective laser trabeculoplasty, ocular rigidity

Eligibility Criteria

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

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

Sites / Locations

  • University Eye Clinic Dresden

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

glaucoma patients

Arm Description

All of the patients treated with SLT need further IOP reduction for control of their glaucoma.

Outcomes

Primary Outcome Measures

change in ocular rigidity
Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?

Secondary Outcome Measures

IOP reduction
Is there an effective IOP drop after SLT?

Full Information

First Posted
November 23, 2010
Last Updated
February 6, 2017
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT01247831
Brief Title
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
Acronym
SLT/ORA
Official Title
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 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
No

5. Study Description

Brief Summary
The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, selective laser trabeculoplasty, ocular rigidity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
glaucoma patients
Arm Type
Other
Arm Description
All of the patients treated with SLT need further IOP reduction for control of their glaucoma.
Intervention Type
Procedure
Intervention Name(s)
Selective Laser Trabeculoplasty
Other Intervention Name(s)
SLT, ORA
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in ocular rigidity
Description
Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
IOP reduction
Description
Is there an effective IOP drop after SLT?
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin R Hornykewycz, MD
Organizational Affiliation
University Eye Clinic Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Clinic Dresden
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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