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Clinical Trials/NCT01495312
NCT01495312
Withdrawn
Not Applicable

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

University of California, San Diego1 site in 1 countryDecember 2011
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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
August 12, 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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