Open Angle Glaucoma With a Progressive Visual FieldBIOLENSNCT01849536
Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
A study testing SENSIMED Triggerfish® in people with Open Angle Glaucoma With a Progressive Visual Field, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma With a Progressive Visual Field
- What is being tested?
- SENSIMED Triggerfish®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Cataract surgery
- High myopia
- Pregnancy and lactation
- Patients not able to understand the character and individual consequences of the investigation
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, 33000
About this study
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.
- Being tested
- SENSIMED Triggerfish®
- Keywords
- Open angle glaucoma, Corneal biomechanics, Intra ocular pressure, IOP, IOP fluctuation, Continuous IOP monitoring, SENSIMED Triggerfish®
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED Triggerfish®Device
| Study group | Role | What they receive |
|---|---|---|
| SENSIMED Triggerfish® | Experimental | SENSIMED Triggerfish® Receives: Device: SENSIMED Triggerfish® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24h
Secondary outcomes (3)
Correlation between visual field defects and IOP fluctuations measurements.
To evaluate the correlation between visual field defects and IOP fluctuations measurements.
Measured: 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.
Measured: 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 ).
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma With a Progressive Visual FieldStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric SCHWEITZER, MD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849536
- Sponsor's protocol ID
- CHUBX 2012/20
- Acronym
- BIOLENS
- Status last verified
- Nov 2013
- First submitted
- 26 Apr 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
- ClinicalTrials.gov ID
- NCT01849536
- Acronym / sponsor ID
- BIOLENS / CHUBX 2012/20
- Keywords
- Open angle glaucoma, Corneal biomechanics, Intra ocular pressure, IOP, IOP fluctuation, Continuous IOP monitoring, SENSIMED Triggerfish®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSIMED Triggerfish® | Experimental | Device: SENSIMED Triggerfish®SENSIMED Triggerfish® |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSIMED Triggerfish® | Device | SENSIMED Triggerfish® |
Primary outcome
Corneal biomechanics influence on IOP fluctuation.
Time frame: 24h
To evaluate corneal biomechanics influence on IOP fluctuation using SENSIMED Triggerfish® for glaucoma patients with a progressive visual field.
3 secondary outcomes
Correlation between visual field defects and IOP fluctuations measurements.
Time frame: 24h
Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements
Time frame: 24h
Lens tolerance and corneal parameters after 24-hours of contact lens wear.
Time frame: 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric SCHWEITZER, MD principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish® in people with Open Angle Glaucoma With a Progressive Visual Field, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal biomechanics influence on IOP fluctuation. (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.