Retinal imaging to detect systemic inflammation in endometriosis

Retinal Imaging for the Assessment of Systemic Inflammation in Endometriosis

This project will test whether quick, noninvasive eye scans can show signs of systemic inflammation in women and people assigned female at birth who have endometriosis by comparing their retinal images with those of similar people without endometriosis.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Edinburgh (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Edinburgh, Scotland)
• Trial ID: NCT07232485 on ClinicalTrials.gov

What this trial studies

This is an exploratory case-control study at the Queen's Medical Research Institute, Edinburgh, comparing retinal scans from people with endometriosis to age-matched people without the condition. Participants undergo noninvasive imaging including optical coherence tomography (OCT), OCT angiography (OCT-A), and ultra-widefield (UWF) imaging, with the eye-imaging visit taking about 30–40 minutes and the full visit around one hour. Those with endometriosis also complete a brief EHP-30 quality-of-life questionnaire and may give a small blood sample to measure markers such as C-reactive protein. The study will analyze retinal structure and microvascular features to see if they correlate with systemic inflammation in endometriosis.

Who should consider this trial

Good fit: Ideal candidates are people aged 18 or older who are pre-menopausal and assigned female at birth, either with a surgical or imaging diagnosis of endometriosis within the past five years or healthy volunteers with no history of endometriosis or chronic pelvic pain.

Not a fit: People with existing ocular diseases that affect retinal structure (for example glaucoma, optic neuropathy, optic neuritis, or significant cataract), known reproductive tract malignancy, recent large blood donation, or those whose endometriosis diagnosis is older than five years may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, this approach could offer a quick, painless way to monitor systemic inflammation and disease activity in people with endometriosis without invasive tests.

How similar studies have performed: Retinal imaging has successfully detected microvascular and inflammatory changes in other systemic conditions such as diabetes and cardiovascular disease, but applying these techniques specifically to endometriosis is largely novel and exploratory.

Eligibility criteria

Inclusion Criteria:

1. Participants with a previous surgical or imaging diagnosis of endometriosis

   * Pre-menopausal women and those assigned female at birth
   * Aged 18 years and over
   * A past surgical or imaging diagnosis of endometriosis within the last 5 years from date of consent
   * Ability to understand and willingness to sign the informed consent form
2. Healthy volunteers

   * Women and those assigned female at birth
   * Aged 18 years and over
   * No history of endometriosis or chronic pelvic pain
   * Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

1. Participants with a previous surgical or imaging diagnosis of endometriosis

   * The subject has donated blood (450 ml) within the last 4 weeks
   * Known reproductive tract malignancy
   * Ocular Diseases:

     * Subjects with clinically diagnosed glaucoma, optic neuropathy, optic neuritis, cataracts, or other conditions that affect the ocular structures.
     * Subjects with age-related macular degeneration, retinal vascular diseases, or other retinal disorders.
     * Subjects with any other ocular conditions that may influence the retinal or optic nerve structure.
   * Refractive Errors:

     * Subjects with high myopia (\>6 diopters) or high hyperopia (\>3 diopters).
     * Subjects with significant astigmatism (\>2 dioptres) or other refractive errors.
   * Ocular Surgery History: Subjects with a history of ocular surgery, particularly involving the lens, cornea, retina, or optic nerve (e.g., laser vision correction, retinal surgeries, etc.).
   * Subjects with significant ocular trauma, corneal abnormalities, or active ocular infections that may interfere with OCT imaging.
   * Subjects with diabetes mellitus
2. Healthy volunteers

   * The subject has donated blood (450 ml) within the last 4 weeks
   * Known reproductive tract malignancy
   * A history of symptoms suggestive of endometriosis or chronic pelvic pain
   * Ocular Diseases:

     * Subjects with clinically diagnosed glaucoma, optic neuropathy, optic neuritis, cataracts, or other conditions that affect the ocular structures.
     * Subjects with age-related macular degeneration, retinal vascular diseases, or other retinal disorders.
     * Subjects with any other ocular conditions that may influence the retinal or optic nerve structure.
   * Refractive Errors:

     * Subjects with high myopia (\>-6 dioptres) or high hyperopia (\>+6 dioptres).
     * Subjects with significant astigmatism (\>2 dioptres) or other refractive errors.
   * Ocular Surgery History: Subjects with a history of ocular surgery, particularly involving the lens, cornea, retina, or optic nerve (e.g., laser vision correction, retinal surgeries, etc.).
   * Subjects with significant ocular trauma, corneal abnormalities, or active ocular infections that may interfere with OCT imaging.
   * Subjects with diabetes mellitus

Where this trial is running

Edinburgh, Scotland

• University of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Andrew Horne — University of Edinburgh
• Study coordinator: Kexin Dong

Conditions Endometriosis; Retinal imaging; Systemic inflammation