PIO Laser Sclerectomy IOP SLT Sclerectomy

NCT ID: NCT01798732

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Primary Open-Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Selective laser trabeculoplasty (Tango Laser, Ellex)

Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)

Group Type EXPERIMENTAL

Selective Laser Trabeculoplasty (Tango Laser, Ellex)

Intervention Type PROCEDURE

One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul ROMANET, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22025580 (View on PubMed)

Other Identifiers

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2010-A00932-37

Identifier Type: OTHER

Identifier Source: secondary_id

1012

Identifier Type: -

Identifier Source: org_study_id