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Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients (BIOLENS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01849536
First received: April 26, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Open Angle Glaucoma With a Progressive Visual Field
Device: SENSIMED Triggerfish®

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Corneal biomechanics influence on IOP fluctuation. [ Time Frame: 24h ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24h ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24h ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).


Enrollment: 30
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENSIMED Triggerfish®
SENSIMED Triggerfish®
Device: SENSIMED Triggerfish®

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849536

Locations
France
Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Cédric SCHWEITZER, MD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01849536     History of Changes
Other Study ID Numbers: CHUBX 2012/20
Study First Received: April 26, 2013
Last Updated: November 21, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Open angle glaucoma
Corneal biomechanics
Intra ocular pressure
IOP
IOP fluctuation
Continuous IOP monitoring
SENSIMED Triggerfish®

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014