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Monitoring of the IOP After SLT Using iCare Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03310788
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Information provided by (Responsible Party):
Enping Chen, St. Erik Eye Hospital

Brief Summary:
The purpose of this study is to investigate how much selective trabeculoplasty (SLT) 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 Primary Pseudo Exfoliation Syndrome

Detailed Description:

Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer, 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. Thereafter, 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. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.

Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2019

Primary Outcome Measures :
  1. Lowering of IOP fluctuations after SLT [ Time Frame: 2 months ]
    The amplitude of the IOP fluctuations pre- and post SLT will be compared

Secondary Outcome Measures :
  1. Lowering of IOP level after SLT [ Time Frame: 2 months ]
    Mean IOP pre- and post SLT

Information from the National Library of Medicine

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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:   Non-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 SLT.

Inclusion Criteria:

  • POAG
  • PXG

Exclusion Criteria:

  • previous SLT
  • reduced hand and arm mobility (e.g. 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 identifier (NCT number): NCT03310788

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Contact: Enping Chen, MD PhD 004686720000
Contact: Laurence Quérat, M Sc 004686723240

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St Erik Eye Hospital Recruiting
Stockholm, Sweden, 11282
Contact: Enping Chen, MD PhD    004686720000   
Contact: Laurence Quérat, M Sc    004686723240   
Sponsors and Collaborators
St. Erik Eye Hospital
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Principal Investigator: Enping Chen, MD Ph D St. Erik Eye Hospital

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Responsible Party: Enping Chen, MD Ph D, St. Erik Eye Hospital Identifier: NCT03310788     History of Changes
Other Study ID Numbers: HOME SLT
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 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: No
Keywords provided by Enping Chen, St. Erik Eye Hospital:
IOP fluctuations
iCare Home
Additional relevant MeSH terms:
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Exfoliation Syndrome
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases