Specular Microscopy in Patients With Proliferative Diabetic Retinopathy

NCT05838898 | Unknown

• 1 other identifier: Specular microscopy
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group. 2\. The effect of the age, and duration of Diabetes on the corneal endothelium .

Conditions

Corneal Endothelial Cell Changes in Diabetic Patients

Outcome Measures

Primary Outcomes (1)

• To predict the effect of Diabetes on the cornea of diabetic patients

  To evaluate corneal endothelial changes in patients with Proliferative diabetic retinopathy compared to normal group of the same age and gender using Specular microscopy

  Baseline

Interventions

Specular microscopy DEVICE

Non-contact Specular microscopy is a non-invasive method that allows for in vivo study of corneal endothelium.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Image capture will be done by the same individual for all subjects. The following data will be collected and analyzed: corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness.

You may qualify if:

• patients with Type I or II Diabetes Mellitus
• Diagnosed with proliferative diabetic retinopathy . .Intraocular pressure less than 21mmHg.
• Healthy controls:
• Healthy individuals aged 40 to 70 years of both sexes. .Intraocular pressure less than 21 mmHg.

You may not qualify if:

• Diabetic group:
• Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
• Previous ocular trauma or surgery.
• Healthy control:
• Any systemic diseases that may affect corneal endothelium function.
• Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
• Previous ocular trauma , surgery ,laser or intraocular injection.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Mortazavi SA, Akhlaghi M, Dehghani A, Pourazizi M, Malekahmadi M, Fazel M, Tavakoli M, Noorshargh P. Diabetic retinopathy and corneal endothelial parameters: an analytical cross-sectional study. BMC Ophthalmol. 2022 Nov 9;22(1):427. doi: 10.1186/s12886-022-02667-6.

  PMID: 36348282 BACKGROUND

• Jha A, Verma A, Alagorie AR. Association of severity of diabetic retinopathy with corneal endothelial and thickness changes in patients with diabetes mellitus. Eye (Lond). 2022 Jun;36(6):1202-1208. doi: 10.1038/s41433-021-01606-x. Epub 2021 Jun 11.

  PMID: 34117392 BACKGROUND

Central Study Contacts

Marline reda, Master

CONTACT

01275986804; Mrmrreda559@gmail.com

Kamel abd el nasser, Professor

CONTACT

01064848401; kamel.atya@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share