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Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure

NCT03689088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-12-04

No results posted yet for this study

Summary

Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities.

The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time.

Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.

Conditions

  • Glaucoma, Open-Angle
  • Healthy

Interventions

DEVICE

Goldfish

Goldfish will be placed in the eye for 24h monitoring

DEVICE

Tonometry

Fellow eye will be measured by tonometry

Sponsors & Collaborators

  • Sensimed AG

    lead INDUSTRY

Principal Investigators

  • Robert Wasilewicz, MD · [W]-Eye Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2018-07-04
Completion
2018-09-06

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03689088 on ClinicalTrials.gov