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

Study Overview
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Brief Summary
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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.

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

Conditions
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Open Angle Glaucoma With a Progressive Visual Field

Intervention / Treatment
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* Device: SENSIMED Triggerfish®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SENSIMED Triggerfish®<br>SENSIMED Triggerfish® | Device: SENSIMED Triggerfish®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal biomechanics influence on IOP fluctuation. | To evaluate corneal biomechanics influence on IOP fluctuation using SENSIMED Triggerfish® for glaucoma patients with a progressive visual field. | 24h | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open angle glaucoma, Corneal biomechanics, Intra ocular pressure, IOP, IOP fluctuation, Continuous IOP monitoring, SENSIMED Triggerfish®