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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01247831
First received: November 23, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
"Primary Open Angle Glaucoma, Ocular Hypertension"
Procedure: Selective Laser Trabeculoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • change in ocular rigidity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Is there a change in ocular rigidtiy (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trebeculoplasty?


Secondary Outcome Measures:
  • IOP reduction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Is there an effective IOP drop after SLT?


Enrollment: 150
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01247831

Locations
Germany
University Eye Clinic Dresden
Dresden, Saxonia, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Karin R Hornykewycz, MD University Eye Clinic Dresden
  More Information

No publications provided

Responsible Party: Dr. Karin Pillunat, Principla Investigator, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01247831     History of Changes
Other Study ID Numbers: SLT/ORA/1
Study First Received: November 23, 2010
Last Updated: December 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
glaucoma, selective laser trabeculoplasty, ocular rigidity

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Muscle Rigidity
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014