R&D of Non-invasive Innovative Intracranial Waves Monitoring System for Diagnostics and Treatment Monitoring of Patients with Normal Tension Glaucoma

NCT ID: NCT06443411

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2025-02-22

Brief Summary

Assessment and monitoring of intracranial pressure (ICP) changes are important in the management of cerebral pathologies. In the eye, ICP increase and decrease both correlate with optic neuropathies, the former because of papilledema and the latter related to glaucoma. While the relationship between ICP elevation and papilledema is well established, the relationship between low ICP and glaucoma is still poorly understood. So far, ICP monitoring is performed invasively, but this entails risks including infection, spurring the study of non-invasive alternatives. While none of currently methods in use can fully replace invasive techniques, certain measures show great potential for specific applications. In this context, monitoring the intracranial pressure changes of normal tension glaucoma may lead to a better understanding of how intracranial pressure waves vary in normal tension glaucoma. Treatment of normal tension glaucoma as a two-pressure disease needs periodic intracranial dynamic monitoring sessions for evaluation of treatment effectiveness and for needed corrections of treatment methodology.

Project aim is to be able to monitor the "missing link" of intracranial dynamics of patients with normal tension glaucoma according to circadian rhythm: in the morning, during lunch and in the evening. The opportunity to monitor ICP waves non-invasively for patients with normal tension glaucoma will be implemented for the first time by using novel non-invasive intracranial pressure waves real-time monitoring system invented by KTU team in 2022 (patent applications are in the process of registration in the EU and USA).

Conditions

Normal Tension Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Glaucoma group

The prospective clinical study will include at least 56 patients with NTG using non-invasive ICP waves monitoring system through a human eye orbit without applying external pressure to the eye with approximately 10 millisecond temporal resolution. It is a prospective longitudinal study of patients with normal tension glaucoma by the inclusion age from 25 to 65 years. The standard monitoring session will last 1-3 minutes. Sex: male and female. Exclusion criterion is documented neurodegenerative disorders.

Monitoring of cerebral hemodynamics

Intervention Type: OTHER

A specially designed pair of goggles will be put on the patient's head. The closed eyelids, along with the surrounding tissues, will be in contact with a thin, elastic, non-allergic film used to seal water filled inside the goggles. Pulse waves, including those originating from cerebrospinal fluid pulsation, will be transmitted from the eyelids to the water, where they will be detected by a pressure sensor and recorded with a laptop.

Control group

100 healthy subjects using non-invasive ICP waves monitoring system through a human eye orbit without applying external pressure to the eye with approximately 10 millisecond temporal resolution.

Monitoring of cerebral hemodynamics

Intervention Type: OTHER

A specially designed pair of goggles will be put on the patient's head. The closed eyelids, along with the surrounding tissues, will be in contact with a thin, elastic, non-allergic film used to seal water filled inside the goggles. Pulse waves, including those originating from cerebrospinal fluid pulsation, will be transmitted from the eyelids to the water, where they will be detected by a pressure sensor and recorded with a laptop.

Interventions

Monitoring of cerebral hemodynamics

A specially designed pair of goggles will be put on the patient's head. The closed eyelids, along with the surrounding tissues, will be in contact with a thin, elastic, non-allergic film used to seal water filled inside the goggles. Pulse waves, including those originating from cerebrospinal fluid pulsation, will be transmitted from the eyelids to the water, where they will be detected by a pressure sensor and recorded with a laptop.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 25-65 years of age.
• The patient, after reading the personal information form, confirms in writing his / her consent to participate in the study.
• The study group includes patients with a primary open-angle normal intraocular pressure glaucoma diagnosis confirmed by an ophthalmologist (typical glaucomatous changes in the optic nerve disc and eye area, open angle of the anterior chamber, intraocular pressure in the diurnal curve with/without anti-glaucoma medication ≤ 21 mmHg) and IOP ≤ 21mmHg on study day with/without anti-glaucoma medication.
• The control group includes healthy volunteers who do not suffer from glaucoma, acute or chronic uncompensated disease that may affect the results of the research, and according to age and anthropometric data correspond to the individuals of other research groups.

Exclusion Criteria

• Patient's refusal to participate in biomedical research.
• Persons younger than 25 years or older than 65 years.
• A woman who may become pregnant, be pregnant or breastfeeding.
• The patient is allergic or sensitive to local anesthetics.
• Suffering from an eye disease that may distort the results of the study, if so decided by the examining physician.
• Patients who have had orbital or eye trauma.
• Patients who have undergone any eye surgery.
• Patients with acute or chronic, but currently aggravated, respiratory system disease.
• Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock).
• Patients with uncompensated diabetes.
• Neurological diseases, mental illnesses identified in the anamnesis.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaunas University of Technology

OTHER

Sponsor Role: collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ugne Kevalaite

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

2024-BE10-0001

Identifier Type: -

Identifier Source: org_study_id