NCT Number: NCT07157553
Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density .
This study investigates the effect of argon laser panretinal photocoagulation (PRP) on the corneal endothelial cell density (ECD) in patients with proliferative diabetic retinopathy (PDR) by comparing ECD measurements before and after PRP treatment.
Trial opening soon.
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About this study
Proliferative diabetic retinopathy (PDR) is characterized by abnormal neovascularization driven by ischemic retinal tissue hypoxia and elevated vascular endothelial growth factor (VEGF) levels. Argon laser retinal photocoagulation (ALRP) is a standard treatment that applies thermal damage to the retinal pigment epithelium, reducing retinal oxygen demand and VEGF production, thereby causing regression of neovascular vessels. However, the laser light must pass through the anterior eye structures, potentially causing thermal and inflammatory damage to tissues such as the corneal endothelium, which is crucial for maintaining corneal transparency. This prospective observational clinical study conducted at Assuit University Hospital evaluates the impact of ALRP on corneal endothelial cell density using specular microscopy before, 1 week, and 1 month after PRP treatment in newly diagnosed PDR patients. Secondary outcomes include changes in cell morphology such as hexagonality and coefficient of variation, indicative of endothelial cell health and stability.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients from either sex with any age newly diagnosed PDR requring PRP .
Exclusion criteria
- history of corneal disease
- previous intraocular surgery
- glaucoma or intraocuar inflamation .
Treatment and study plan
Primary outcomes
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Change in Corneal Endothelial Cell Density (ECD) after PRP
Time frame: baseline
The primary outcome is the quantitative change in the corneal endothelial cell density measured by specular microscopy, comparing pre-treatment baseline values with post-treatment values at 1 week and 1 month intervals. This measure reflects the potential impact of ALRP on the corneal endothelial integrity, crucial for corneal transparency and function.
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Official study title
Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density Among Patients With Proliferative Diabetic Retinopathy .
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Sep 5, 2025
- Registry last updated
- Sep 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.