Diabetic RetinopathyNCT06154746
Analysis of Risk Factors of Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Assiut University.
Trial summary
The aim of the study is to analyse the risk factors involved in the development of diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- slit lamb & OCT
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2025
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population-based, cross-sectional survey using the standardised Rapid Assessment of Avoidable Blindness with the addition of the Diabetic Retinopathy module methodology.
Who may be able to join
- All patients with confirmed DR , best-corrected visual acuity BCVA (using a Snellen chart) in each eye to allow the performance of the protocol, and intraocular pressure less than 21 mmHg.
- . proliferative diabetic retinopathy with or without high-risk characteristics (HRCs) (any three of the following):
- presence of neovessels
- location of the neovessels (at the optic nerve)
- size of the neovessels: if at the optic nerve [neovascularisation of the disc (NVD)] ≥ ¼-⅓ disc area if elsewhere in the retina [neovascularisation of the retina elsewhere (outside the disc) (NVE) ≥ ½ of the disc area (if both NVD and NVE present, classified based on neovessels at the disc)
- presence of pre-retinal haemorrhage or vitreous haemorrhage. About half of patients with severe or very severe NPDR will progress to PDR within a year.
- Symptoms include sudden de crease of V/A , appearance of flashes and floaters, visual field defects.
Who cannot join
- The exclusion criteria were: DM other than T2DM (such as gestational diabetes); known severe mental illness; a separate advanced or terminal condition; and severe advanced diabetic complications defined as being registered blind, requiring dialysis, or having had an above-the-knee amputation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Risk Factors in the Development of Diabetic Retinopathy in Assuit University Hospital
The aim of the study is to analyse the risk factors involved in the development of diabetic retinopathy.
Read the detailed description
Introduction Worldwide, diabetic retinopathy (DR) is the leading cause of blindness among working age adults [1]
Diabetes mellitus (diabetes) is a group of conditions in which elevation and dysregulation of blood glucose levels result from either decreased production of insulin or systemic resistance to insulin's effects.
Economic costs of diabetes in the. U.S. in 2012. Diabetes Care. 2013;36(4):1033-46.
Insulin resistance, which often precedes type 2 diabetes, is a component of the metabolic syndrome. Those with diabetes are more likely to have other components of the metabolic syndrome including abdominal obesity, dyslipidemia, hypertension, prothrombotic state, and a proinflammatory state [2] Third Report of the National Cholesterol Education Program. (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-421
Another key point for the development of vascular lesions is the capillary basement membrane thickening as a result of hyperglycemia, increased synthesis of basement membrane components and other factors. This thickening of the basement membrane is related to excess vascular permeability that leads to leaky vessels, compromised tight-junctions and increased vesicular transport [3]
Although major risk factors-hyperglycemia and hypertension-are extensively studied and show a strong association with DR
Some studies indicate that prolonged DM duration is indeed a well-established risk factor for DR [4-5]. Regarding microalbuminuria, studies report its association as a marker of microvascular dysfunction and DR [6-7], however further studies are needed to confirm this relationship [6]. Other risk factors such as body mass index (BMI) show controversies in relation to its association with this disease [8]. The aim of this study was to investigate risk factors for DR.
Diabetic retinopathy is the leading cause of blindness in adults living in developed countries.9 Almost all patients with type 1 diabetes mellitus (DM) and more than 60% of patients with type 2 DM will develop some degree of retinopathy after a 20-year history of diabetes.10 It has also been well established that DM increases the risk of cardiovascular disease.
- Conditions
- Diabetic Retinopathy
- Being tested
- slit lamb & OCT
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slit lamb & OCTDiagnostic test
- The Slit lamb is a biomicroscope. It emits a beam of light that can be varied in height and width. It allows visualization of the anterior segment of the eye. With auxiliary lenses, the examiner can also view the posterior segment. These lenses are simple, affordable, and portable. Although high-end devices like fundus cameras and optical coherence tomography have revolutionized how practitioners detect eye diseases, they can never replace these handheld lenses.
- OCT is a noninvasive method that yields a cross-section image of the retina by exposing the eye to near-infrared light. Specifically, an emitted light beam is scattered and reflected back by the retinal surface as well as its different layers.
What is being measured
The primary outcome is the main question the study is designed to answer.
aeffect of risk factors in progression of diabetic retinopathy.
analysis of risk factors affecting progression of diabetic retinopathy and test if they can be modified or not.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startJun 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Mahmoud Asem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154746
- Sponsor's protocol ID
- risk factors of DR
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors in the Development of Diabetic Retinopathy in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT06154746
- Acronym / sponsor ID
- risk factors of DR
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Dec 2023 (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 aim of the study is to analyse the risk factors involved in the development of diabetic retinopathy.
Detailed description
Introduction Worldwide, diabetic retinopathy (DR) is the leading cause of blindness among working age adults [1]
Diabetes mellitus (diabetes) is a group of conditions in which elevation and dysregulation of blood glucose levels result from either decreased production of insulin or systemic resistance to insulin's effects.
Economic costs of diabetes in the. U.S. in 2012. Diabetes Care. 2013;36(4):1033-46.
Insulin resistance, which often precedes type 2 diabetes, is a component of the metabolic syndrome. Those with diabetes are more likely to have other components of the metabolic syndrome including abdominal obesity, dyslipidemia, hypertension, prothrombotic state, and a proinflammatory state [2] Third Report of the National Cholesterol Education Program. (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-421
Another key point for the development of vascular lesions is the capillary basement membrane thickening as a result of hyperglycemia, increased synthesis of basement membrane components and other factors. This thickening of the basement membrane is related to excess vascular permeability that leads to leaky vessels, compromised tight-junctions and increased vesicular transport [3]
Although major risk factors-hyperglycemia and hypertension-are extensively studied and show a strong association with DR
Some studies indicate that prolonged DM duration is indeed a well-established risk factor for DR [4-5]. Regarding microalbuminuria, studies report its association as a marker of microvascular dysfunction and DR [6-7], however further studies are needed to confirm this relationship [6]. Other risk factors such as body mass index (BMI) show controversies in relation to its association with this disease [8]. The aim of this study was to investigate risk factors for DR.
Diabetic retinopathy is the leading cause of blindness in adults living in developed countries.9 Almost all patients with type 1 diabetes mellitus (DM) and more than 60% of patients with type 2 DM will develop some degree of retinopathy after a 20-year history of diabetes.10 It has also been well established that DM increases the risk of cardiovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population-based, cross-sectional survey using the standardised Rapid Assessment of Avoidable Blindness with the addition of the Diabetic Retinopathy module methodology.
Key inclusion criteria (7 listed)
- All patients with confirmed DR , best-corrected visual acuity BCVA (using a Snellen chart) in each eye to allow the performance of the protocol, and intraocular pressure less than 21 mmHg.
- . proliferative diabetic retinopathy with or without high-risk characteristics (HRCs) (any three of the following):
- presence of neovessels
- location of the neovessels (at the optic nerve)
- size of the neovessels: if at the optic nerve [neovascularisation of the disc (NVD)] ≥ ¼-⅓ disc area if elsewhere in the retina [neovascularisation of the retina elsewhere (outside the disc) (NVE) ≥ ½ of the disc area (if both NVD and NVE present, classified based on neovessels at the disc)
Key exclusion criteria (1 listed)
- The exclusion criteria were: DM other than T2DM (such as gestational diabetes); known severe mental illness; a separate advanced or terminal condition; and severe advanced diabetic complications defined as being registered blind, requiring dialysis, or having had an above-the-knee amputation
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 |
|---|---|---|
| slit lamb & OCT1. The Slit lamb is a biomicroscope. It emits a beam of light that can be varied in height and width. It allows visualization of the anterior segment of the eye. With auxiliary lenses, the examiner can also view the posterior segment. These lenses are simple, affordable, and portable. Although high-end devices like fundus cameras and optical coherence tomography have revolutionized how practitioners detect eye diseases, they can never replace these handheld lenses. 2. OCT is a noninvasive method that yields a cross-section image of the retina by exposing the eye to near-infrared light. Specifically, an emitted light beam is scattered and reflected back by the retinal surface as well as its different layers. | Diagnostic test | – |
Primary outcome
aeffect of risk factors in progression of diabetic retinopathy.
Time frame: baseline
analysis of risk factors affecting progression of diabetic retinopathy and test if they can be modified or not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Assiut University.
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 7 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 dalia asem, Bachelor's degree (01033343611, daliaasem8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aeffect of risk factors in progression of diabetic retinopathy. (time frame: baseline). 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 4 Dec 2023.