PIO Laser Sclerectomy IOP SLT Sclerectomy | NCT01798732 | Trialant

PIO Laser Sclerectomy IOP SLT Sclerectomy | NCT01798732 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Selective laser trabeculoplasty (Tango Laser, Ellex)	Experimental	Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)	Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selective Laser Trabeculoplasty (Tango Laser, Ellex)	Procedure	One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22025580	Background	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.