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IOP Monitoring After Trabeculectomy Using iCare Home

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ClinicalTrials.gov Identifier: NCT03445806
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Enping Chen, St. Erik Eye Hospital

Brief Summary:
The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Condition or disease
Glaucoma, Open-Angle Pseudo Exfoliation Syndrome

Detailed Description:

Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.

In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.

Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IOP Monitoring After Trabeculectomy Using iCare Home
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma




Primary Outcome Measures :
  1. Lowering of IOP levels after trabeculectomy [ Time Frame: 2-3 months ]
    Mean (SD) IOP pre- and post trabeculectomy


Secondary Outcome Measures :
  1. Lowering of IOP fluctuations after trabeculectomy [ Time Frame: 2-3 months ]
    Mean (SD) IOP range pre- and post trabeculectomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.
Criteria

Inclusion Criteria:

  • POAG
  • PXG

Exclusion Criteria:

  • previous trabeculectomy
  • reduced hand and arm mobility (e. due to rheumatism)

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): NCT03445806


Contacts
Contact: Amelie Botling Taube, MD PhD 00466720000 amelie.botling-taube@sll.se
Contact: Laurence Quérat, MSc 00468723240 laurence.querat@live.se

Locations
Sweden
St Erik Eye Hospital Recruiting
Stockholm, Sweden, 11282
Contact: Enping Chen, MD PhD    004686720000    enping.chen@sll.se   
Contact: Laurence Quérat, M Sc    004686723240    laurence.querat@sll.se   
Sponsors and Collaborators
St. Erik Eye Hospital

Responsible Party: Enping Chen, Principal Investigator, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT03445806     History of Changes
Other Study ID Numbers: Home Trab
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enping Chen, St. Erik Eye Hospital:
IOP fluctuations
iCare Home
Trabeculectomy
self-tonometry

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Exfoliation Syndrome
Glaucoma
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases