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Assessment of Home Tonometry in Glaucoma

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ClinicalTrials.gov Identifier: NCT03057301
Recruitment Status : Unknown
Verified February 2017 by NHS Lothian.
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

Brief Summary:

Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is known to vary throughout the day and in ¾ of people is highest during the night. The result is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this might have on their glaucoma. This is a serious limitation as the treatment of glaucoma depends on lowering IOP.

Recently a new device has become available, designed specifically for home IOP monitoring. The iCare HOME tonometer is a CE marked commercial device (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain insight into 24-hour IOP fluctuations. We wish to determine the feasibility of home IOP monitoring using this device. The iCare HOME tonometer depends on the patient performing self-tonometry. Testing one's own IOP may be technically difficult and it is likely that large numbers of patients will struggle with this.


Condition or disease Intervention/treatment
Glaucoma Intraocular Pressure Device: iCare home tonometer

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Home Tonometry in Glaucoma
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : March 1, 2017
Estimated Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Device: iCare home tonometer
    All subjects will be taught to use the home care tonometer.


Primary Outcome Measures :
  1. Whether or not the subject is deemed successful in using the home tonometer [ Time Frame: On baseline visit ]
    Strict success = intraocular pressure within 5mmHg of that obtained by technician



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with glaucoma attending a university hospital glaucoma clinic.
Criteria

Inclusion Criteria:

  • Glaucoma
  • At least 4 previous visual field tests (to enable rate of change to be calculated).
  • Age 16 years and above
  • Age less than 100

Exclusion Criteria:

  • Corneal disease (potentially affects pressure measurements)
  • Neovascular glaucoma
  • Uveitis
  • Secondary glaucomas
  • Inability to give informed consent.
  • Less than 16 years of age.
  • Pregnancy.
  • Unable to hold iCare HOME® tonometer due to upper limb weakness or disability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057301


Contacts
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Contact: Margaret McDonald 441315363902 margaret.l.macdonald@nhslothian.scot.nhs.uk
Contact: Andrew Tatham, FRCOphth 441315363902 atatham@nhs.net

Locations
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United Kingdom
Princess Alexandra Eye Pavilion Recruiting
Edinburgh, Midlothian, United Kingdom, EH39HA
Contact: Margaret McDonald    441315363902    margaret.l.mcdonald@nhslothian.scot.nhs.uk   
Principal Investigator: Andrew J Tatham, FRCOphth         
Sponsors and Collaborators
NHS Lothian
Investigators
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Principal Investigator: Andrew J Tatham, FRCOphth NHS Lothian
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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT03057301    
Other Study ID Numbers: AC16040
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases