Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
Primary Purpose
Diabetic Retinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Optical coherence tomography (OCTA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, optical coherence tomography, fluorescein angiography, diabetes mellitus
Eligibility Criteria
Inclusion Criteria: emmetropia slight refractive error best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes Exclusion Criteria: general disease that by its nature affects or can affect the retina and the vascular system of the eye concomitant vascular or other retinal diseases
Sites / Locations
- University Hospital OstravaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy pediatric patients
Children with diabetes mellitus
Arm Description
Healthy pediatric patients will undergo optical coherence tomography.
Children with diabetes mellitus will undergo optical coherence tomography.
Outcomes
Primary Outcome Measures
Vascular density in central and peripheral retina - healthy subjects
The primary goal of the project is measurement of vascular density in central and peripheral retina in healthy subjects using OCT Spectralis (Heidelberg Engineering, Germany). Vascular density is ratio between areas with and without vascular tissue. Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from healthy individuals 6-15 years old.
Secondary Outcome Measures
Vascular density in central and peripheral retina - diabetic patients
The secondary goal of the project is measurement of vascular density in central and peripheral retina in diabetic patients using OCT Spectralis (Heidelberg Engineering, Germany). Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from diabetic patients 6-15 years old shortly after being diagnosed and compared with results obtained in the healthy group.
Full Information
NCT ID
NCT05615740
First Posted
October 27, 2022
Last Updated
November 7, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT05615740
Brief Title
Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
Official Title
Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of the project is to create a normative database from data collected from a healthy pediatric population. A secondary aim is to compare normative data with data from pediatric patients with pre-existing type 1 diabetes mellitus.
Detailed Description
Diabetic retinopathy, or damage to the retina caused by diabetes, is one of the most common complications in all patients with newly diagnosed diabetes mellitus of both types. These are mainly pathological changes affecting the vascular supply of the retina, which precede changes affecting the peripheral nervous system.
Children and in general patients with type I diabetes mellitus are around 0.6% of the population in the long term. the first changes in the retinal vessels can usually be expected after 2-5 years from the first detection of the disease. These changes are diagnosed using a biomicroscopic examination of the fundus.
Until recently, the only possible examination method was fluorescein angiography (FAG). It is an invasive examination with a fluorescein solution administered into a peripheral vein through a cannula and further photo documentation of the flow dynamics through the vascular bed in blue (cobalt) light. The flow time in individual phases of filling is recorded.
The disadvantage is the necessary cooperation of the child, the need to establish peripheral venous access, the risk of an allergic reaction to the contrast material, and the duration of the examination lasting two or more hours.
These disadvantages disappeared with the advent of optical coherence tomography and the angiographic mode - OCTA.
OCTA can detect the passage of individual blood elements (mostly erythrocytes) through capillaries and larger vessels in real-time and thus compile maps of individual vascular networks in the retina and choroid. The advantage is that the examination is not invasive, it is not necessary to inject a dye into the patient's bloodstream and no special preparation is required. The device is classified as a Class 1 laser, which is safe for the human eye. The examination is not painful or uncomfortable.
Due to the relatively short period of use in practice, there is still a lack of data from findings in a healthy population. In the past, normative databases of adult patients were compiled for comparing the state of the healthy central area of the eye using OCTA. Data for the child population, especially the Central European one, is missing or has been collected on a small sample only.
The primary goal of the project is to create a normative database from data collected from a healthy pediatric population. A secondary aim is to compare normative data with data from pediatric patients with pre-existing type 1 diabetes mellitus.
It is anticipated that 100-150 children aged 6-15 will be enrolled at the Centre for Visually Impaired Children of the University of Ostrava as part of regular check-ups. Depending on the degree of cooperation of the child, the examination takes around two minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, optical coherence tomography, fluorescein angiography, diabetes mellitus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be enrolled into two groups - healthy pediatric population and children with diabetes mellitus.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy pediatric patients
Arm Type
Active Comparator
Arm Description
Healthy pediatric patients will undergo optical coherence tomography.
Arm Title
Children with diabetes mellitus
Arm Type
Active Comparator
Arm Description
Children with diabetes mellitus will undergo optical coherence tomography.
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography (OCTA)
Intervention Description
OCTA can detect the passage of individual blood elements (mostly erythrocytes) through capillaries and larger vessels in real-time
Primary Outcome Measure Information:
Title
Vascular density in central and peripheral retina - healthy subjects
Description
The primary goal of the project is measurement of vascular density in central and peripheral retina in healthy subjects using OCT Spectralis (Heidelberg Engineering, Germany). Vascular density is ratio between areas with and without vascular tissue. Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from healthy individuals 6-15 years old.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Vascular density in central and peripheral retina - diabetic patients
Description
The secondary goal of the project is measurement of vascular density in central and peripheral retina in diabetic patients using OCT Spectralis (Heidelberg Engineering, Germany). Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from diabetic patients 6-15 years old shortly after being diagnosed and compared with results obtained in the healthy group.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
emmetropia
slight refractive error
best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes
Exclusion Criteria:
general disease that by its nature affects or can affect the retina and the vascular system of the eye
concomitant vascular or other retinal diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Koubek, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Michal Koubek, MD
First Name & Middle Initial & Last Name & Degree
Jan Němčanský, MD,PhD,MBA
First Name & Middle Initial & Last Name & Degree
Jiří Strnadel, MD
First Name & Middle Initial & Last Name & Degree
Juraj Timkovič, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. These may be provided upon request.
Learn more about this trial
Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
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