Monitoring of the IOP After SLT Using iCare Home

Glaucoma Open-Angle Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310788
• Other study ID #: HOME SLT
• Status: Recruiting
• Start date: October 3, 2017
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2021
• Source: St. Erik Eye Hospital
• Contact: Enping Chen, MD PhD
• Phone: 004686720000
• Email: enping.chen[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• POAG

• PXG

Exclusion Criteria:

• previous SLT

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

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma Open-Angle Primary
• Glaucoma, Open-Angle
• Pseudo Exfoliation Syndrome

Locations

Country	Name	City	State
Sweden	St Erik Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowering of IOP fluctuations after SLT	The amplitude of the IOP fluctuations pre- and post SLT will be compared	2 months
Secondary	Lowering of IOP level after SLT	Mean IOP pre- and post SLT	2 months