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PIO Laser Sclerectomy IOP SLT Sclerectomy (PIO laser SPNP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798732
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.

Condition or disease Intervention/treatment Phase
Primary Open-Angle Glaucoma Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.
Study Start Date : August 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selective laser trabeculoplasty (Tango Laser, Ellex)
Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)
Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)
One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)




Primary Outcome Measures :
  1. IOP change over 24 hours after selective trabeculoplasty SLT according to chronobiological data (decrease of IOP; type of 24h-IOP rhythm and 24h-PPm rhythm: MESOR, acrophase, bathyphase, amplitude and modeling) [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT. [ Time Frame: Baseline and 6 months ]
    • To find predictive factors 1 month before efficacy of the treatment (after 6 month). Efficacy is defined by a mean IOP decrease, at least 30%, with a smoothed pressure-peaks (decrease at least 40% of pressure changes)
    • To characterize changes of ocular blood flow parameters (optic nerve head; Volume, Velocity and Flow): 20% at least of increase.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Open-Angle Glaucoma
  • IOP more than 21 mmHg
  • Progression under maximal medical therapy
  • aged more than 18 years

Exclusion Criteria:

  • Pregnant woman

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): NCT01798732


Locations
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France
University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean-Paul ROMANET, Pr University Hospital, Grenoble
Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01798732    
Other Study ID Numbers: 1012
2010-A00932-37 ( Other Identifier: ID RCB )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases