NCT01495312
Withdrawn
Not Applicable
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
ConditionsGlaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- University of California, San Diego
- Locations
- 1
- Primary Endpoint
- IOP
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eunice Williams-Steppe
Research Associate
University of California, San Diego
Eligibility Criteria
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
Outcomes
Primary Outcomes
IOP
Time Frame: 2 months after SLT
Study Sites (1)
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