Retinal Imaging for Systemic Inflammation in Endometriosis
Recruiting · NCT07232485 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Edinburgh
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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 it is running
1 location listed.
- University of Edinburgh - Edinburgh, Scotland, United Kingdom