PIO Laser Sclerectomy IOP SLT Sclerectomy

Not Applicable

Completed

• Conditions: Primary Open-Angle Glaucoma
• Interventions: Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)

• Registration Number: NCT01798732
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-26
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selective laser trabeculoplasty (Tango Laser, Ellex)	Selective Laser Trabeculoplasty (Tango Laser, Ellex)	Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	* 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.

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France