SENSIMED Triggerfish Discomfort During IOP Monitoring

NCT ID: NCT00966108

Last Updated: 2010-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-01-31

Brief Summary

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Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Detailed Description

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Conditions

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Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy subjects

SENSIMED Triggerfish

Intervention Type DEVICE

Ocular Telemetry Sensor for IOP monitoring

Glaucoma patients

SENSIMED Triggerfish

Intervention Type DEVICE

Ocular Telemetry Sensor for IOP monitoring

Interventions

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SENSIMED Triggerfish

Ocular Telemetry Sensor for IOP monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is able to comply with the study procedure
* Patient is 18-80 years old
* Healthy subject or glaucoma patient
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Cylinder refraction of no more than +/- 2 diopters in the study eye
* Visual acuity of 20/80 or better in the study eye
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception

Exclusion Criteria

* Subjects wearing contact lenses within the last two years
* Subjects with contraindications for wearing contact lenses
* History of refractive surgery
* History of intraocular surgery in the last three months
* Severe dry eye syndrome
* Keratoconus or other corneal abnormalities
* Conjunctival or intraocular inflammation
* Pregnancy and lactation
* Simultaneous participation in other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Principal Investigators

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Norbert Pfeiffer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mainz

Locations

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Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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09/02

Identifier Type: -

Identifier Source: org_study_id

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