The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

May 9, 2011 updated by: University of Toronto
Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows progressive damage with characteristic loss of visual field. Glaucoma is very commonly associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown to increase when lying down in normal subjects as well as patients with glaucoma. It is possible that this effect can make glaucoma worse. This study is designed to investigate the effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each patient will be required to attend for 2 separate 24 hour visits. On one visit the patient will be required to sleep flat and on the other visit at a 30° head up sleeping position. During this time the patient will be required to wear a soft contact lens (SENSIMED Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP measurements are wirelessly transmitted to a recorder.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Graham E Trope, PhD, FRCSC
        • Sub-Investigator:
          • Yvonne M Buys, MD, FRCSC
        • Sub-Investigator:
          • Hussain Patel, MD
        • Sub-Investigator:
          • John Flanagan, DO, PhD
        • Sub-Investigator:
          • Colin Shapiro, MD, PhD
        • Sub-Investigator:
          • Farzana Jahan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Glaucoma clinic patients

Description

Inclusion Criteria:

  • signed informed consent
  • diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) that is progressing based on recent or recurrent optic disc hemorrhage
  • age 18-85 years
  • not more than 4 diopters of spherical equivalent or 2 diopters of cylinder equivalent in study eye
  • stable anti-glaucoma treatment for 4 weeks before first session
  • for women of childbearing potential, adequate contraception

Exclusion Criteria:

  • unwilling or unable to sleep in a flat or 30 degrees head up position
  • ocular surgery in previous 3 months
  • corneal or conjunctival abnormality
  • wear of full frame metallic glasses during monitoring session
  • severe dry eye
  • secondary forms of glaucoma
  • allergy to corneal anaesthesia
  • patients with contraindications for contact lens wear
  • pregnancy and lactation
  • patients unable to understand the character and individual consequences of the investigation
  • simultaneous participation in other research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure changes that occur during sleep and with changes in body posture
Time Frame: 24 hours
The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device
Time Frame: 24 hours
Patients will be monitored for contact lens related side effects or adverse effects that occur during the monitoring session.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Sensimed AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 11, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0844-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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