Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients (BIOLENS)
Primary Purpose
Open Angle Glaucoma With a Progressive Visual Field
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SENSIMED Triggerfish®
Sponsored by
About this trial
This is an interventional diagnostic trial for Open Angle Glaucoma With a Progressive Visual Field focused on measuring Open angle glaucoma, Corneal biomechanics, Intra ocular pressure, IOP, IOP fluctuation, Continuous IOP monitoring, SENSIMED Triggerfish®
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
Sites / Locations
- Service d'ophtalmologie Hôpital Pellegrin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SENSIMED Triggerfish®
Arm Description
SENSIMED Triggerfish®
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Correlation between visual field defects and IOP fluctuations measurements.
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
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.
To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).
Full Information
NCT ID
NCT01849536
First Posted
April 26, 2013
Last Updated
November 21, 2013
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01849536
Brief Title
Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
Acronym
BIOLENS
Official Title
Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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®
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish®
Arm Type
Experimental
Arm Description
SENSIMED Triggerfish®
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish®
Primary Outcome Measure Information:
Title
Corneal biomechanics influence on IOP fluctuation.
Description
To evaluate corneal biomechanics influence on IOP fluctuation using SENSIMED Triggerfish® for glaucoma patients with a progressive visual field.
Time Frame
24h
Secondary Outcome Measure Information:
Title
Correlation between visual field defects and IOP fluctuations measurements.
Description
To evaluate the correlation between visual field defects and IOP fluctuations measurements.
Time Frame
24h
Title
Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements
Description
To evaluate the correlation between the severity of optic nerve head damages measured with OCT and IOP fluctuations measurements.
Time Frame
24h
Title
Lens tolerance and corneal parameters after 24-hours of contact lens wear.
Description
To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).
Time Frame
24h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric SCHWEITZER, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'ophtalmologie Hôpital Pellegrin
City
CHU de Bordeaux
State/Province
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
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Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
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