Retinal Imaging for Systemic Inflammation in Endometriosis

NCT07232485 | Recruiting

• 1 other identifier: 25/WS/0103
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing evidence that examining our eyes can tell us a lot of information about our health, and systemic diseases. Our plan is to compare the images taken of the back of eyes of women who have endometriosis with those of women who don't. We want to study what eyes can reveal about endometriosis by analyzing the retinal images from a simple noninvasive eye scan, that is already being routinely used to provide immediate clinical information in other groups of patients (eg. diabetic eye screening).

Conditions

Endometriosis

Keywords

Endometriosis; Retinal imaging; Systemic inflammation

Outcome Measures

Primary Outcomes (5)

• Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)

  Choroidal thickness quantified from OCT cross-sectional scans using the Heidelberg SPECTRALIS platform to compare endometriosis cases with matched controls at baseline. Unit of Measure: micrometers (µm).

  Baseline

• Retinal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)

  Full-thickness retinal measurements derived from OCT (Heidelberg SPECTRALIS) for between-group comparison at baseline. Unit of Measure: micrometers (µm).

  Baseline

• Retinal Nerve Fiber Layer (RNFL) Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)

  RNFL thickness obtained on OCT for baseline comparison between endometriosis and matched controls. Unit of Measure: micrometers (µm).

  Baseline

• Macular Volume (Optical Coherence Tomography, Heidelberg SPECTRALIS)

  Macular volume derived from OCT volume scans for baseline between-group comparison. Unit of Measure: cubic millimeters (mm³).

  Baseline

• Retinal Vessel Density (Optical Coherence Tomography Angiography, Heidelberg SPECTRALIS)

  OCT-A-based vessel density (non-invasive angiography) used to characterize retinal microvasculature for baseline between-group comparison. Unit of Measure: percent (%).

  Baseline

Secondary Outcomes (10)

• Change from Baseline in Choroidal Thickness

  Baseline; and post-intervention at 3-6 months after surgery or new hormonal treatment; or 4-8 weeks after completion of an endometriosis-related clinical trial; assessments occur within up to 3 years of baseline.

• Change from Baseline in Retinal Thickness

  Baseline; and post-intervention at 3-6 months after surgery or new hormonal treatment; or 4-8 weeks after completion of an endometriosis-related clinical trial; assessments occur within up to 3 years of baseline.

• Change from Baseline in RNFL Thickness

  Baseline; and post-intervention at 3-6 months after surgery or new hormonal treatment; or 4-8 weeks after completion of an endometriosis-related clinical trial; assessments occur within up to 3 years of baseline.

• Change from Baseline in Macular Volume

  Baseline; and post-intervention at 3-6 months after surgery or new hormonal treatment; or 4-8 weeks after completion of an endometriosis-related clinical trial; assessments occur within up to 3 years of baseline.

• Change from Baseline in Retinal Vessel Density

  Baseline; and post-intervention at 3-6 months after surgery or new hormonal treatment; or 4-8 weeks after completion of an endometriosis-related clinical trial; assessments occur within up to 3 years of baseline.

Study Arms (2)

Endometriosis women

Pre-menopausal women with a previous surgical or imaging diagnosis of endometriosis

Healthy volunteers

Pre-menopausal women with no history of endometriosis or chronic pelvic pain

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women and those assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a matched case-control study. We will recruit 50 women with endometriosis (case) and 50 women matched for age without endometriosis (controls).

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Healthy volunteers
• The subject has donated blood (450 ml) within the last 4 weeks

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, EH16 4UU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be taken from participants. We will keep the samples until they are used up. This may be at least 10 years.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andrew Horne

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kexin Dong

CONTACT

+447301394870; K.Dong-2@sms.ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: November 18, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Selected anonymised data and samples collected or generated by the study may be shared with academic or industry partners within the UK from the start of the study (expected start date: 01/10/2025). Research data will be archived and stored on secure servers hosted by The University of Edinburgh (in Data Store) for 10 years.
• Access Criteria: Who can access: Authorized study team and Co-Sponsor (University of Edinburgh/NHS Lothian) for conduct/monitoring/audit/archiving; Research Ethics Committee and regulators may inspect records. External academic/industry collaborators may receive selected anonymised participant-level data and anonymised surplus samples per PIS/consent; identifiable data are not released. What: De-identified eCRF data (demographics, clinical characteristics, retinal imaging metrics, questionnaire scores, lab reports) and, where applicable, anonymised surplus biosamples. How: Internal data stored in validated REDCap on secure University servers with user authentication; personal identifiers held separately; participants assigned unique study IDs (pseudonymised). External sharing only in anonymised form, under Sponsor approval and data-sharing agreements, with secure transfer. Data controller: Co-Sponsor; retention: ≥5 years for personal data, 10 years for research data.

Locations

GB (1)