Retinal Imaging for the Assessment of Systemic Inflammation in Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)
研究概览
简要总结
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).
详细描述
What this study is about Endometriosis is now understood to affect the whole body, not just the pelvis. Many individuals with endometriosis show signs of low-grade systemic inflammation. The eye offers clinicians a clear, painless window on tiny blood vessels. Modern retinal scans can measure structure and blood flow at the back of the eye within minutes. This study will test whether retinal scans can serve as a non-invasive read-out of systemic inflammation in endometriosis. If successful, this approach could support assessment and longitudinal monitoring.
What will happen in the study
This is an exploratory case-control study. Women with endometriosis and age-matched women without endometriosis will be invited for a research visit at the Queen's Medical Research Institute (QMRI), Edinburgh. All participants will undergo the following retinal imaging:
Optical Coherence Tomography (OCT): a quick scan showing retinal and choroidal layers.
OCT Angiography (OCT-A): a map of tiny retinal vessels without dye injections. Ultra-widefield (UWF) imaging (Optos): a large-field retinal image. Scans are painless, non-invasive, and similar to routine eye assessments. The eye-imaging component takes about 30-40 minutes; the entire visit lasts about 1 hour.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)
时间窗: Baseline
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).
Retinal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)
时间窗: Baseline
Full-thickness retinal measurements derived from OCT (Heidelberg SPECTRALIS) for between-group comparison at baseline. Unit of Measure: micrometers (µm).
Retinal Nerve Fiber Layer (RNFL) Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)
时间窗: Baseline
RNFL thickness obtained on OCT for baseline comparison between endometriosis and matched controls. Unit of Measure: micrometers (µm).
Macular Volume (Optical Coherence Tomography, Heidelberg SPECTRALIS)
时间窗: Baseline
Macular volume derived from OCT volume scans for baseline between-group comparison. Unit of Measure: cubic millimeters (mm³).
Retinal Vessel Density (Optical Coherence Tomography Angiography, Heidelberg SPECTRALIS)
时间窗: Baseline
OCT-A-based vessel density (non-invasive angiography) used to characterize retinal microvasculature for baseline between-group comparison. Unit of Measure: percent (%).
次要结局
- 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.)
- Correlation Between Serum C-reactive Protein and Choroidal Thickness (OCT)(Baseline and post intervention (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))
- Correlation Between Serum C-reactive Protein and Retinal Thickness (OCT)(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.)
- Correlation Between Serum C-reactive Protein and RNFL Thickness (OCT)(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.)
- Correlation Between Serum C-reactive Protein and Macular Volume (OCT)(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.)
- Correlation Between Serum C-reactive Protein and Retinal Vessel Density (OCT Angiography)(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.)