GOLDING: Glaucoma Telemedicine Screening

Sponsor
University Hospital Olomouc (Other)
Overall Status
Recruiting
CT.gov ID
NCT05446363
Collaborator
Palacky University (Other)
200
1
5
39.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Medimonitor

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Glaucoma Telemedicine Screening
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Successful fundus imaging of 90 % enrolled patients. [3 month]

    90% of captured fundus images are useful for subsequent diagnostics by the ophthalmologist located remotely.

  2. Successful intraocular pressure measurement of 90 % enrolled patients. [3 month]

    90% of measured intraocular pressures are useful for subsequent diagnostics by the ophthalmologist located remotely.

  3. Invitation of all suspected patients within 1 month timeframe after the diagnosis to the premises of University hospital Olomouc for aditional assessment. [4 month]

    Patients that were identified as suspected by the funduscopy and intraocular tonometry are subsequently invited for further assessment into the hospital.

  4. Successful stratification of 90 % enrolled patients into groups with use of intraocular tonometer. [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)

  5. Successful stratification of 90 % enrolled patients into groups with use of fundus camera. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ≥ 18 years of age

  • Informed written and verbal consent

Exclusion Criteria:

• Absence of collaboration (informed consent)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ordinace Pospíšil Postřelmov Czechia 789 69

Sponsors and Collaborators

  • University Hospital Olomouc
  • Palacky University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ladislav Stanke, Principal Investigator, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT05446363
Other Study ID Numbers:
  • GOLDING
First Posted:
Jul 6, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022