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

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ClinicalTrials.gov Identifier: NCT01247831
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Technische Universität Dresden

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

Condition or disease Intervention/treatment
Glaucoma Procedure: Selective Laser Trabeculoplasty

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  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
Study Start Date : November 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. IOP reduction [ Time Frame: 4 weeks ]
    Is there an effective IOP drop after SLT?



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Karin Pillunat, Principla Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01247831     History of Changes
Other Study ID Numbers: SLT/ORA/1
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Dr. Karin Pillunat, Technische Universität Dresden:
glaucoma, selective laser trabeculoplasty, ocular rigidity

Additional relevant MeSH terms:
Glaucoma
Muscle Rigidity
Ocular Hypertension
Eye Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms