Optical Coherence Tomography Angiography Evaluation Of Patients Taking Hydroxychloroquine

This study aims to evaluate retinal and choroidal microvascular changes using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy. Hydroxychloroquine is commonly used in the treatment of autoimmune diseases and may cause retinal toxicity with long-term use. OCTA is a non-invasive imaging modality that allows detailed assessment of retinal vascular changes.

Study Overview

• Status: Not yet recruiting
• Conditions: Hydroxychloroquine Retinopathy

Detailed Description

Hydroxychloroquine is widely prescribed for the management of autoimmune and rheumatologic diseases. Long-term use of hydroxychloroquine has been associated with retinal toxicity, which may lead to irreversible visual impairment if not detected early. Conventional screening methods include fundus examination, automated visual field testing, and spectral-domain optical coherence tomography.

Optical coherence tomography angiography (OCTA) is a non-invasive imaging technique that enables quantitative and qualitative assessment of retinal and choroidal microvasculature. This study is designed to evaluate OCTA parameters in patients receiving hydroxychloroquine therapy.

Patients undergoing hydroxychloroquine treatment will be evaluated using OCTA imaging. Retinal vascular parameters will be analyzed and correlated with clinical variables such as duration of treatment and cumulative hydroxychloroquine dose. The findings of this study may contribute to improved understanding of early microvascular changes associated with hydroxychloroquine exposure and the potential role of OCTA in retinal toxicity screening.

• Study Type: Observational
• Enrollment (Estimated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study includes adults receiving hydroxychloroquine therapy for autoimmune diseases and a control group of healthy volunteers. The aim is to evaluate retinal microvascular changes using OCTA imaging.

Description

Inclusion Criteria:

• Adults (≥18 years old) with documented HCQ therapy for ≥1 year.
• Stable systemic disease under medical supervision.

Exclusion Criteria:

• -patients with media opacity.
• Any pre-existing retinal or optic nerve disease (e.g., diabetic retinopathy, AMD, myopic degeneration).
• History of intraocular surgery or trauma.
• Uncontrolled systemic vascular diseases (e.g., hypertension)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Capillary Plexus Vessel Density (SCP)	Measurement of superficial capillary plexus vessel density using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy.	Day 1
Deep Capillary Plexus Vessel Density (DCP)	Measurement of deep capillary plexus vessel density using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy.	Day 1

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SMohamedAhmed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No