PIO Laser Sclerectomy IOP SLT Sclerectomy

Primary Open-Angle Glaucoma Clinical Trial

— PIO laser SPNP  

Official title:

Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798732
• Other study ID #: 1012
• Secondary ID: 2010-A00932-37
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: November 14, 2014
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open-Angle Glaucoma

Intervention

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)

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline and 6 months	No