GlaucomaGOLDINGNCT05446363
Glaucoma Telemedicine Screening
An observational study of Glaucoma, run by University Hospital Olomouc at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Medimonitor
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General public of remote regions without available specialized ophthalmology deparments.
Who may be able to join
- ≥ 18 years of age
- Informed written and verbal consent
Who cannot join
- Absence of collaboration (informed consent)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Ordinace Pospíšil
Postřelmov, 789 69
Zdeněk Pospíšil, MD
About this study
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.
Read the 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
- Being tested
- Medimonitor
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedimonitorDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful fundus imaging of 90 % enrolled patients.
90% of captured fundus images are useful for subsequent diagnostics by the ophthalmologist located remotely.
Measured: 3 month
Successful intraocular pressure measurement of 90 % enrolled patients.
90% of measured intraocular pressures are useful for subsequent diagnostics by the ophthalmologist located remotely.
Measured: 3 month
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.
Measured: 4 month
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)
Measured: 4 month
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)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Ladislav Stanke, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446363
- Sponsor's protocol ID
- GOLDING
- Acronym
- GOLDING
- Status last verified
- Jan 2024
- First submitted
- 1 Jul 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Telemedicine Screening
- ClinicalTrials.gov ID
- NCT05446363
- Acronym / sponsor ID
- GOLDING / GOLDING
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General public of remote regions without available specialized ophthalmology deparments.
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Informed written and verbal consent
Key exclusion criteria (1 listed)
- Absence of collaboration (informed consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedimonitorA 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. | Device | – |
Primary outcome
Successful fundus imaging of 90 % enrolled patients.
Time frame: 3 month
90% of captured fundus images are useful for subsequent diagnostics by the ophthalmologist located remotely.
Successful intraocular pressure measurement of 90 % enrolled patients.
Time frame: 3 month
90% of measured intraocular pressures are useful for subsequent diagnostics by the ophthalmologist located remotely.
Invitation of all suspected patients within 1 month timeframe after the diagnosis to the premises of University hospital Olomouc for aditional assessment.
Time frame: 4 month
Patients that were identified as suspected by the funduscopy and intraocular tonometry are subsequently invited for further assessment into the hospital.
Successful stratification of 90 % enrolled patients into groups with use of intraocular tonometer.
Time frame: 4 month
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)
Successful stratification of 90 % enrolled patients into groups with use of fundus camera.
Time frame: 4 month
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladislav Stanke, Ph.D. (+420 588 443 713, ladislav.stanke@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful fundus imaging of 90 % enrolled patients. (time frame: 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.