Status:
COMPLETED
Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Open Angle Glaucoma With a Progressive Visual Field
Eligibility:
All Genders
40+ years
Phase:
NA
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 alt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01849536
Start Date
January 1 2013
End Date
October 1 2013
Last Update
November 25 2013
Active Locations (1)
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1
Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, France, 33000