Clinical trial NCT01849536: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
Official title: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma With a Progressive Visual Field
Keywords: Open angle glaucoma
Corneal biomechanics
Intra ocular pressure
IOP
IOP fluctuation
Continuous IOP monitoring
SENSIMED Triggerfish®
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Corneal biomechanics influence on IOP fluctuation.
timeFrame: 24h
Secondary outcomes:
measure: Correlation between visual field defects and IOP fluctuations measurements.
timeFrame: 24h
measure: Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements
timeFrame: 24h
measure: Lens tolerance and corneal parameters after 24-hours of contact lens wear.
timeFrame: 24h
Other outcomes:
Locations:
city: CHU de Bordeaux
country: France
facility: Service d'ophtalmologie Hôpital Pellegrin
state: Bordeaux
Study officials:
affiliation: University Hospital Bordeaux, France
name: Cédric SCHWEITZER, MD
role: PRINCIPAL_INVESTIGATOR
References: