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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENSIMED Triggerfish® | Experimental | SENSIMED Triggerfish® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish® | Device |
|
| 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 |
| 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 |
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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:
Open angle glaucoma patients with a progressive visual field
For women of childbearing potential, adequate contraception
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cédric SCHWEITZER, MD | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'ophtalmologie Hôpital Pellegrin | CHU de Bordeaux | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 |