Analysis of Risk Factors of Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Analysis of Risk Factors in the Development of Diabetic Retinopathy in Assuit University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154746
• Other study ID #: risk factors of DR
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: dalia asem, Bachelor's degree
• Phone: 01033343611
• Email: daliaasem8[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to analyse the risk factors involved in the development of diabetic retinopathy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria:

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-? 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Diagnostic Test:
• slit lamb & OCT
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline