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

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 Overview

• Status: Completed
• Conditions: Open Angle Glaucoma With a Progressive Visual Field
• Intervention / Treatment: Device: SENSIMED Triggerfish®

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux
    • CHU de Bordeaux, Bordeaux, France, 33000
      • Service d'ophtalmologie Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENSIMED Triggerfish®	Device: SENSIMED Triggerfish®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between visual field defects and IOP fluctuations measurements.	To evaluate the correlation between visual field defects and IOP fluctuations measurements.	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.	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 ).	24h

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Cédric SCHWEITZER, MD, University Hospital Bordeaux, France

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: IOP; Open angle glaucoma; Corneal biomechanics; Intra ocular pressure; IOP fluctuation; Continuous IOP monitoring; SENSIMED Triggerfish®
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: CHUBX 2012/20