Study Stopped
Due to staff departures unable to execute this study so requested closure. There were no study procedures performed \& no participants enrolled.
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2013
CompletedMay 30, 2019
May 1, 2019
8 months
December 12, 2011
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IOP
2 months after SLT
Study Arms (1)
SLT
EXPERIMENTALInterventions
SLT (single session; 180 to 360 degrees of angle will be treated)
Eligibility Criteria
You may qualify if:
- Subject is able to comply with the study procedures
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UCSD
La Jolla, California, 92037, United States
UCSD
La Jolla, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 20, 2011
Study Start
December 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 12, 2013
Last Updated
May 30, 2019
Record last verified: 2019-05