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OpenTrials
Completed

NCT Number: NCT01849536

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

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.

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Key information

Conditions

Open Angle Glaucoma With a Progressive Visual Field Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'ophtalmologie Hôpital Pellegrin

CHU de Bordeaux, Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish®

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation between visual field defects and IOP fluctuations measurements.

    Time frame: 24h

    To evaluate the correlation between visual field defects and IOP fluctuations measurements.

  2. Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements

    Time frame: 24h

    To evaluate the correlation between the severity of optic nerve head damages measured with OCT and IOP fluctuations measurements.

  3. Lens tolerance and corneal parameters after 24-hours of contact lens wear.

    Time frame: 24h

    To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: BIOLENS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 8, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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