BIOLENS: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01849536

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP circadian rhythm is altered and varied widely between patients. To date, the only way to evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour hospitalization. This method is expensive and does not reflect physiological conditions because it requires IOP measurements during sleeping periods that may potentially produce artifacts.

Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. Then we will also analyze the influence of corneal parameters on continuous IOP fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma With a Progressive Visual Field	Device: SENSIMED Triggerfish®	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SENSIMED Triggerfish® SENSIMED Triggerfish®	Device: SENSIMED Triggerfish®

Arm

Intervention/Treatment

Experimental: SENSIMED Triggerfish®

SENSIMED Triggerfish®

Device: SENSIMED Triggerfish®

Outcome Measures

Primary Outcome Measures

Corneal biomechanics influence on IOP fluctuation. [24h]
To evaluate corneal biomechanics influence on IOP fluctuation using SENSIMED Triggerfish® for glaucoma patients with a progressive visual field.

Secondary Outcome Measures

Correlation between visual field defects and IOP fluctuations measurements. [24h]
To evaluate the correlation between visual field defects and IOP fluctuations measurements.
Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements [24h]
To evaluate the correlation between the severity of optic nerve head damages measured with OCT and IOP fluctuations measurements.
Lens tolerance and corneal parameters after 24-hours of contact lens wear. [24h]
To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 40 year-old
Signed informed consent
Visual field defect : at least 2 visual field already done, only the second one is considered for the visual field defect diagnosis, using theses criterion:
3 adjacent points with at least 5db loss
Or 1 point with at least 10 db loss
Or a 10db difference between two adjacent points on either sides of the nasal horizontal meridian
Open angle glaucoma patients with a progressive visual field
For women of childbearing potential, adequate contraception

Exclusion Criteria:

Corneal dystrophy, scars or corneal surgery
Iridocorneal angle opening less than 3 using Shaeffer classification
History of glaucoma surgery
Any contraindications with the SENSIMED Triggerfish® device, as written in the user manual (active eye disease, severe dry eye, contraindications for silicone contact lens wear…)
Diabetes
Sleep Apnea Syndromes
Cataract surgery
High myopia
Pregnancy and lactation
Patients not able to understand the character and individual consequences of the investigation