Analysis of Risk Factors of Diabetic Retinopathy

NCT06154746 | Unknown

• 1 other identifier: risk factors of DR
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

slit lamb & OCT DIAGNOSTIC_TEST

1. 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.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population-based, cross-sectional survey using the standardised Rapid Assessment of Avoidable Blindness with the addition of the Diabetic Retinopathy module methodology.

You may qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

dalia asem, Bachelor's degree

CONTACT

01033343611; daliaasem8@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11