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PIO Laser Sclerectomy IOP SLT Sclerectomy (PIO laser SPNP)

Primary Purpose

Primary Open-Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Selective Laser Trabeculoplasty (Tango Laser, Ellex)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-Angle Glaucoma

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital of Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selective laser trabeculoplasty (Tango Laser, Ellex)

Arm Description

Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.
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.

Full Information

First Posted
December 12, 2012
Last Updated
November 14, 2014
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01798732
Brief Title
PIO Laser Sclerectomy IOP SLT Sclerectomy
Acronym
PIO laser SPNP
Official Title
Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Selective laser trabeculoplasty (Tango Laser, Ellex)
Arm Type
Experimental
Arm Description
Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)
Intervention Type
Procedure
Intervention Name(s)
Selective Laser Trabeculoplasty (Tango Laser, Ellex)
Intervention Description
One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul ROMANET, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22025580
Citation
Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.
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PIO Laser Sclerectomy IOP SLT Sclerectomy

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