Glaucoma Telemedicine Screening

Glaucoma Clinical Trial

— GOLDING  

Official title:

Glaucoma Telemedicine Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446363
• Other study ID #: GOLDING
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Hospital Olomouc
• Contact: Ladislav Stanke, Ph.D.
• Phone: +420 588 443 713
• Email: ladislav.stanke[@]fnol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• Informed written and verbal consent

Exclusion Criteria:

• Absence of collaboration (informed consent)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Czechia	Ordinace Pospíšil	Postrelmov

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful fundus imaging of 90 % enrolled patients.	90% of captured fundus images are useful for subsequent diagnostics by the ophthalmologist located remotely.	3 month
Primary	Successful intraocular pressure measurement of 90 % enrolled patients.	90% of measured intraocular pressures are useful for subsequent diagnostics by the ophthalmologist located remotely.	3 month
Primary	Invitation of all suspected patients within 1 month timeframe after the diagnosis to the premises of University hospital Olomouc for aditional assessment.	Patients that were identified as suspected by the funduscopy and intraocular tonometry are subsequently invited for further assessment into the hospital.	4 month
Primary	Successful stratification of 90 % enrolled patients into groups with use of intraocular tonometer.	Differentiation of 90 % enrolled patients into the following groups: patients with ocular hypertension (higher intraocular pressure); patients with normotensive glaucoma (normal intraocular pressure); glaucoma patients (higher intraocular pressure)	4 month
Primary	Successful stratification of 90 % enrolled patients into groups with use of fundus camera.	Differentiation of 90 % enrolled patients into the following groups: patients with ocular hypertension (normal optic disc); patients with normotensive glaucoma (suspected optic disc); glaucoma patients (suspected optic disc)	4 month