Hydroxychloroquine RetinopathyNCT07409740
Optical Coherence Tomography Angiography Evaluation Of Patients Taking Hydroxychloroquine
An observational study of Hydroxychloroquine Retinopathy, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hydroxychloroquine Retinopathy
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults (≥18 years old) with documented HCQ therapy for ≥1 year.
- Stable systemic disease under medical supervision.
Who cannot join
- -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)
About this study
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.
Read the 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.
- Conditions
- Hydroxychloroquine Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial Capillary Plexus Vessel Density (SCP)
Measurement of superficial capillary plexus vessel density using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydroxychloroquine RetinopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409740
- Sponsor's protocol ID
- SMohamedAhmed
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Evaluation Of Patients Taking Hydroxychloroquine
- ClinicalTrials.gov ID
- NCT07409740
- Acronym / sponsor ID
- SMohamedAhmed
- Conditions
- Hydroxychloroquine Retinopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults (≥18 years old) with documented HCQ therapy for ≥1 year.
- Stable systemic disease under medical supervision.
Key exclusion criteria (4 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Superficial Capillary Plexus Vessel Density (SCP)
Time frame: Day 1
Measurement of superficial capillary plexus vessel density using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy.
Deep Capillary Plexus Vessel Density (DCP)
Time frame: Day 1
Measurement of deep capillary plexus vessel density using optical coherence tomography angiography (OCTA) in patients receiving hydroxychloroquine therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydroxychloroquine Retinopathy, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial Capillary Plexus Vessel Density (SCP) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.