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

NCT ID: NCT01495312

Last Updated: 2019-05-30

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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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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SLT

Group Type EXPERIMENTAL

SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish

Intervention Type DEVICE

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

Interventions

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SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Eunice Williams-Steppe

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD

La Jolla, California, United States

Site Status

UCSD

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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TFSLT1

Identifier Type: -

Identifier Source: org_study_id

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