Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density .

NCT ID: NCT07157553

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Panretinal Photocoagulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The study population consists of 45 newly diagnosed patients of any age or sex with proliferative di

The inclusion criteria cover patients irrespective of age or sex who are newly diagnosed with proliferative diabetic retinopathy and are indicated for argon laser panretinal photocoagulation. Exclusion criteria include any history of corneal disease, previous intraocular surgeries, glaucoma, or intraocular inflammation to reduce confounding factors affecting corneal endothelial measurements. This helps to ensure that changes detected in corneal endothelial cell density and morphology are primarily attributable to the laser intervention rather than underlying ocular comorbidities. The sample size calculation determined that 45 patients would provide sufficient power to detect statistically significant changes, analyzed using paired t-tests and ANOVA for repeated measures.

No interventions assigned to this group

Eligibility Criteria

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 .

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahlam Abdelhady Mohamad Omar

resident doctor at Ophthalmology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.

Reference Type: BACKGROUND

PMID: 7526212 (View on PubMed)

Other Identifiers

argon laser photocoagulation

Identifier Type: -

Identifier Source: org_study_id