24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery

Glaucoma Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01495299
• Other study ID #: TDCAT1
• Status: Withdrawn
• Start date: December 2011
• Est. completion date: October 2012

Study information

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

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, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

• 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

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:
• Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish
Phacoemulsification (standard cataract extraction surgery)

Locations

Country	Name	City	State
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	24-h IOP patterns		24 hour