Study Stopped
Due to staff departures we were unable to execute this study
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
1 other identifier
observational
N/A
1 country
1
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, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Shorter than P25 for all trials
1 active site
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
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedAugust 21, 2019
August 1, 2019
10 months
December 12, 2011
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-h IOP patterns
24 hour
Study Arms (1)
cataract patients with glaucoma
Interventions
Phacoemulsification (standard cataract extraction surgery)
Eligibility Criteria
glaucoma patients scheduled to undergo cataract surgery.
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
- Presence of cataract requiring phacoemulsification with lens exchange
- 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 (1)
UCSD
La Jolla, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 20, 2011
Study Start
December 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
August 21, 2019
Record last verified: 2019-08