PIO laser SPNP: PIO Laser Sclerectomy IOP SLT Sclerectomy

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Completed
• CT.gov ID: NCT01798732
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-Angle Glaucoma	Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selective laser trabeculoplasty (Tango Laser, Ellex) Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)	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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Grenoble	Grenoble		France

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

• Principal Investigator: Jean-Paul ROMANET, Pr, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT01798732
• Other Study ID Numbers: 1012; 2010-A00932-37
• First Posted: Feb 26, 2013
• Last Update Posted: Nov 17, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Glaucoma, Open-Angle

Study Results

No Results Posted as of Nov 17, 2014