Monitoring of the IOP After SLT Using iCare Home

Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home

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).

Study Overview

• Status: Recruiting
• Conditions: Pseudo Exfoliation Syndrome; Glaucoma Open-Angle Primary

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Enping Chen, MD PhD; Phone Number: 004686720000; Email: enping.chen@sll.se
• Study Contact Backup: Name: Laurence Quérat, M Sc; Phone Number: 004686723240; Email: laurence.querat@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11282
    • Recruiting
    • St Erik Eye Hospital
    • Contact: Enping Chen, MD PhD; Phone Number: 004686720000; Email: enping.chen@sll.se
    • Contact: Laurence Quérat, M Sc; Phone Number: 004686723240; Email: laurence.querat@sll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• POAG
• PXG

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowering of IOP fluctuations after SLT	The amplitude of the IOP fluctuations pre- and post SLT will be compared	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowering of IOP level after SLT	Mean IOP pre- and post SLT	2 months

Collaborators and Investigators

• Sponsor: St. Erik Eye Hospital
• Investigators: Principal Investigator: Enping Chen, MD Ph D, St. Erik Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: IOP fluctuations; iCare Home; self-tonometry; SLT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Uveal Diseases; Glaucoma; Iris Diseases; Glaucoma, Open-Angle; Exfoliation Syndrome
• Other Study ID Numbers: HOME SLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No