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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01495312
• Other study ID #: TFSLT1
• Status: Withdrawn
• Phase: N/A
• Start date: December 2011
• Est. completion date: August 12, 2013

Study information

• Verified date: May 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 12, 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
SLT (single session; 180 to 360 degrees of angle will be treated)

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California
United States	UCSD	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP		2 months after SLT