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24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01495312
Enrollment
0
Registered
2011-12-20
Start date
2011-12-31
Completion date
2013-08-12
Last updated
2019-05-30

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

Conditions

Glaucoma

Keywords

IOP fluctuations, during two 24-hour periods

Brief summary

The purpose of this study is to determine the relationship between Intraocular Pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.

Interventions

DEVICESLT (selective laser trabeculoplasty ) SENSIMED Triggerfish

SLT (single session; 180 to 360 degrees of angle will be treated)

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation. * Subject is able to comply with the study procedures * 18-80 years old * Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \> 22 mmHg at the screening visit and under ocular hypotensive treatment. * Subject has consented to be in the trial * Visual acuity of 20/200 or better * Ability to understand the character and individual consequences of the study * For women of childbearing potential, adequate contraception

Exclusion criteria

* Subjects presenting with any of the following criteria will not be included in the trial: * Subjects with contraindications for wearing contact lenses * Severe dry eye syndrome * Keratoconus or other corneal abnormality * Conjunctival or intraocular inflammation * Eye surgery prior to and throughout the study. * Full frame metal glasses during SENSIMED Triggerfish® monitoring * Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) * Pregnancy and lactation * Simultaneous participation in other clinical studies

Design outcomes

Primary

MeasureTime frame
IOP2 months after SLT

Countries

United States

Outcome results

None listed

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