Glaucoma Telemedicine Screening

NCT ID: NCT05446363

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-31

Brief Summary

The incidence of glaucoma is currently growing in the world's population, including the younger ones. However, the number of specialists who could perform examinations is unavailable in many areas of the Czech Republic outside large agglomerations. There is suitable alternative procedure that would make it possible to increase the intensity of screening, for example in general practitioners surgeries via application of teleophthalmology. Early detection is absolutely essential for the patient (and therefore the health care system) for his/her further successful treatment. At the same time, all the necessary technical prerequisites are well known and commercially available.

Detailed Description

Detailed Description: The aim of this study is to increase the detection of patients suspected of having glaucoma. For this purpose, the use of a combination of a mobile fundus camera and a mobile intraocular tonometer is proposed. These devices are used within the general practitioners' surgeries in the rural parts of Olomouc and Jeseniky region. Their combination will allow a better stratification of patients suspected of glaucoma into the following groups:

• patients with ocular hypertension (higher intraocular pressure and normal optic disc)
• patients with normotensive glaucoma (normal intraocular pressure and suspected optic disc)
• glaucoma patients (higher intraocular pressure and suspected optic disc)

The advantage of involving a fundus camera is also in the possibility of the retinal pathologies detection such as diabetic retinopathy or age-related macular degeneration as a secondary outcome of the study.

However, the primary goal of the study is to detect glaucoma and ocular hypertension. This area is also supported by the Risk Factors Questionnaire and the Patient Education Questionnaire.

All patients will be evaluated by University hospital Olomouc (FNOL) ophthalmology specialists who will evaluate data coming through the specifically designed FNOL telemedicine webportal from intraocular tonometers and fundus cameras. Suspected patients will be invited to the FNOL Eye Clinic for follow-up assessment using other modalities - perimeter, OCT, stationary fundus camera, etc.

The secondary goal of the project is to create a database combining retinal images with intraocular pressure values, and data from other modalities in suspected patients who come to the FNOL for follow-up examinations. This goal will support the epidemiological study as well as it opens up the possibility of building a neural network over the database for easier classification of glaucoma patients in the future.

As cognitive impairments (for instance Alzheimer's disease) can also be inferred with the above-described equipment, patients are also presented with a questionnaire to examine their cognitive performance. Data collected with use of questionnaires will be also part of the database. Consequently, presenting the tertiary outcome of the described study.

Conditions

Glaucoma

Study Design

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

Interventions

Medimonitor

A digital solution consisting of web based portal gathering data from mobile fundus camera and intraocular tonometer provided to the physicians located remotely to the University hospital that provides consults and analyses of on-site gathered data.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years of age
• Informed written and verbal consent

Exclusion Criteria

• Absence of collaboration (informed consent)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Palacky University

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: lead

Responsible Party

Ladislav Stanke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ordinace Pospíšil

Postřelmov, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Ladislav Stanke, Ph.D.

Role: CONTACT

ladislav.stanke@fnol.cz

+420 588 443 713

Facility Contacts

Zdeněk Pospíšil, MD

Role: primary

Other Identifiers

GOLDING

Identifier Type: -

Identifier Source: org_study_id