NCT07409740

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 28, 2026

Last Update Submit

February 8, 2026

Conditions

Hydroxychloroquine Retinopathy

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology resident

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-01