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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01495312
• Collaborator: (none)
• Enrollment: 0
• Locations: 2
• Arm: 1
• Duration (Months): 20.4
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Anticipated Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 12, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SLT	Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish; SLT (single session; 180 to 360 degrees of angle will be treated)

Outcome Measures

Primary Outcome Measures

1. IOP [2 months after SLT]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD	La Jolla	California	United States	92037
2	UCSD	La Jolla	California	United States

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eunice Williams-Steppe, Research Associate, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01495312
• Other Study ID Numbers: TFSLT1
• First Posted: Dec 20, 2011
• Last Update Posted: May 30, 2019
• Last Verified: May 1, 2019

• Keywords provided by Eunice Williams-Steppe, Research Associate, University of California, San Diego: IOP fluctuations; during two 24-hour periods
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of May 30, 2019