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Completed

NCT Number: NCT01798732

PIO Laser Sclerectomy IOP SLT Sclerectomy

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.

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Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Grenoble

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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)

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: PIO laser SPNP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2013
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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