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

Not Applicable

Withdrawn

• Conditions: Glaucoma
• Interventions: Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish

• Registration Number: NCT01495312
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-20
• Primary Completion: 2012-08
• Study Completion: 2013-08-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SLT	SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish	-

Primary Outcome Measures

Name	Time	Method
IOP	2 months after SLT

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States