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PIO Laser Sclerectomy IOP SLT Sclerectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01798732
Acronym
PIO laser SPNP
Enrollment
26
Registered
2013-02-26
Start date
2011-08-31
Completion date
2014-11-30
Last updated
2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-Angle Glaucoma

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.

Interventions

PROCEDURESelective 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)

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026