PIO Laser Sclerectomy IOP SLT Sclerectomy
PIO laser SPNP
Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 17, 2014
November 1, 2014
3.3 years
December 12, 2012
November 14, 2014
Conditions
Outcome Measures
Primary Outcomes (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)
Baseline and 6 months
Secondary Outcomes (1)
Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.
Baseline and 6 months
Study Arms (1)
Selective laser trabeculoplasty (Tango Laser, Ellex)
EXPERIMENTALPatients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)
Interventions
One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)
Eligibility Criteria
You may qualify if:
- Primary Open-Angle Glaucoma
- IOP more than 21 mmHg
- Progression under maximal medical therapy
- aged more than 18 years
You may not qualify if:
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Grenoble
Grenoble, France
Related Publications (1)
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.
PMID: 22025580BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Paul ROMANET, Pr
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2012
First Posted
February 26, 2013
Study Start
August 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 17, 2014
Record last verified: 2014-11