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

NCT01849536 | Completed DMC

• 1 other identifier: CHUBX 2012/20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Open Angle Glaucoma With a Progressive Visual Field

Keywords

Open angle glaucoma; Corneal biomechanics; Intra ocular pressure; IOP; IOP fluctuation; Continuous IOP monitoring; SENSIMED Triggerfish®

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between visual field defects and IOP fluctuations measurements.

  24h

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

  24h

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

  24h

Study Arms (1)

SENSIMED Triggerfish®

EXPERIMENTAL

SENSIMED Triggerfish®

Device: SENSIMED Triggerfish®

Interventions

SENSIMED Triggerfish® DEVICE

SENSIMED Triggerfish®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service d'ophtalmologie Hôpital Pellegrin

CHU de Bordeaux, Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Cédric SCHWEITZER, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 8, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

FR (1)