Suspended

A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression

What is being tested

SENSIMED Triggerfish®

Device

Who is being recruted

Eye Diseases+1

+ Glaucoma

+ Ocular Hypertension

From 40 to 89 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorSensimed AG

Last updated: October 9, 2020

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.

NCT01828255

Principal SponsorSensimed AG

Last updated: October 9, 2020

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesGlaucomaOcular HypertensionGlaucoma, Open-Angle

Criteria

9 inclusion criteria required to participate

Age between 40 and 89 years old

All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period

At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%

Diagnosis of treated POAG (including normal tension glaucoma (NTG))

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9 exclusion criteria prevent from participating

Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'

Corneal or conjunctival abnormality precluding contact lens adaptation

Participation in unrelated clinical research within the last 4 weeks

Patients not able to understand the character and individual consequences of the investigation

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The New York Eye and Ear Infirmary

New York, United StatesOpen The New York Eye and Ear Infirmary in Google Maps

SuspendedOne Study Center