Clinical trial NCT05446363: Glaucoma Telemedicine Screening
Official title: Glaucoma Telemedicine Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2022-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General public of remote regions without available specialized ophthalmology deparments.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Absence of collaboration (informed consent)

Primary outcomes:
measure: Successful fundus imaging of 90 % enrolled patients.
timeFrame: 3 month
measure: Successful intraocular pressure measurement of 90 % enrolled patients.
timeFrame: 3 month
measure: Invitation of all suspected patients within 1 month timeframe after the diagnosis to the premises of University hospital Olomouc for aditional assessment.
timeFrame: 4 month
measure: Successful stratification of 90 % enrolled patients into groups with use of intraocular tonometer.
timeFrame: 4 month
measure: Successful stratification of 90 % enrolled patients into groups with use of fundus camera.
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Postřelmov
country: Czechia
facility: Ordinace Pospíšil
Study officials:
References: