EndometriosisRISENCT07232485
Retinal Imaging for Systemic Inflammation in Endometriosis
An observational study of Endometriosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2025to Sep 2029
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, Scotland, EH16 4UU
Kexin Dong, 07301394870, K.Dong-2@sms.ed.ac.uk
About this study
Official title: Retinal Imaging for the Assessment of Systemic Inflammation in Endometriosis
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).
Read the detailed description
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.
Participants with endometriosis will also complete a brief endometriosis-specific quality-of-life questionnaire (EHP-30) before imaging. A small blood sample (up to 40 mL) may be taken to measure C-reactive protein (CRP) and other inflammation markers immediately or in the future (with consent). Any surplus samples may be stored securely for related research. Healthy volunteers attend a single visit only. Participants with endometriosis may be invited for repeat assessments after treatment - for example, 3 - 6 months after surgery or initiation of new hormonal therapy, or 4 - 8 weeks after completing an endometriosis-related clinical trial - to repeat the same assessments.
Burden, risks, and discomforts Retinal imaging does not use ionising radiation and is considered low risk. Possible short-lived effects include eye strain or mild headache from fixation on a target light. Venepuncture may cause brief discomfort or mild bruising. Breaks will be scheduled if needed, and expected effects will be recorded in the study file.
Measurements and analyses Scan-derived measurements will include retinal thickness, retinal nerve fibre layer thickness, macular volume, choroidal thickness, and retinal micro-vessel features. Between-group differences (endometriosis vs controls) will be analysed. Associations with blood inflammation markers will be assessed, and changes after treatment will be evaluated.
Data handling and confidentiality Study data are recorded in a case report form and entered into a secure REDCap database hosted by the University of Edinburgh. Personal details (e.g., contact information) are stored separately on secure systems with restricted access. Research data are pseudonymised using study ID codes. Data are retained and archived according to University/NHS Sponsor policies and UK data-protection law. Selected anonymised data and samples may be shared with academic or industry partners as described in the consent documents. Participation is voluntary, and participants may withdraw at any time; data collected up to withdrawal are retained for scientific and regulatory integrity.
Oversight and approvals The study is co-sponsored by the University of Edinburgh and NHS Lothian (ACCORD) and conducted in line with Good Clinical Practice (GCP) and all required approvals. Monitoring or audit may occur according to Sponsor procedures. The study ends after the last participant's last visit; a summary will be provided to the Research Ethics Committee.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Retinal imaging, Systemic inflammation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: Baseline
Secondary outcomes (10)
Change from Baseline in Choroidal Thickness
Within-participant change from baseline to the relevant post-intervention time point(s).
Unit of Measure: micrometers (µm).
Measured: 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
Within-participant change from baseline to post-intervention. Unit of Measure: micrometers (µm).
Measured: 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
Description: Within-participant change from baseline to post-intervention. Unit of Measure: micrometers (µm).
Measured: 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
Within-participant change from baseline to post-intervention. Unit of Measure: cubic millimeters (mm³).
Measured: 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
Within-participant change from baseline to post-intervention using OCT-A vessel density.
Unit of Measure: percent (%).
Measured: 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)
Association between serum CRP concentration (laboratory assay, mg/L) and choroidal thickness (OCT, µm). Pearson or Spearman as appropriate per analysis plan.
Unit of Measure: correlation coefficient r (unitless).
Measured: 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)
Association between serum CRP (mg/L) and retinal thickness (µm). Unit of Measure: correlation coefficient r (unitless).
Measured: 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)
Association between serum CRP (mg/L) and RNFL thickness (µm). Unit of Measure: correlation coefficient r (unitless).
Measured: 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)
Association between serum CRP (mg/L) and macular volume (mm³). Unit of Measure: correlation coefficient r (unitless).
Measured: 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)
Association between serum CRP (mg/L) and retinal vessel density (%) from OCT-A. Unit of Measure: correlation coefficient r (unitless).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start3 Sep 2025
- Primary completionAug 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Horne, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232485
- Sponsor's protocol ID
- 25/WS/0103
- Acronym
- RISE
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What IPD: De-identified participant-level datasets and surplus biological samples as applicable. With Whom/Conditions: Academic or industry partners, as described in the PIS/consent; no release of identifiable data; publications contain no personal data. How/Where: Secure transfer under data-sharing agreements; data stored in validated REDCap with controlled access.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Imaging for the Assessment of Systemic Inflammation in Endometriosis
- ClinicalTrials.gov ID
- NCT07232485
- Acronym / sponsor ID
- RISE / 25/WS/0103
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Retinal imaging, Systemic inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 Nov 2025 (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.
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).
Detailed description
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.
Participants with endometriosis will also complete a brief endometriosis-specific quality-of-life questionnaire (EHP-30) before imaging. A small blood sample (up to 40 mL) may be taken to measure C-reactive protein (CRP) and other inflammation markers immediately or in the future (with consent). Any surplus samples may be stored securely for related research. Healthy volunteers attend a single visit only. Participants with endometriosis may be invited for repeat assessments after treatment - for example, 3 - 6 months after surgery or initiation of new hormonal therapy, or 4 - 8 weeks after completing an endometriosis-related clinical trial - to repeat the same assessments.
Burden, risks, and discomforts Retinal imaging does not use ionising radiation and is considered low risk. Possible short-lived effects include eye strain or mild headache from fixation on a target light. Venepuncture may cause brief discomfort or mild bruising. Breaks will be scheduled if needed, and expected effects will be recorded in the study file.
Measurements and analyses Scan-derived measurements will include retinal thickness, retinal nerve fibre layer thickness, macular volume, choroidal thickness, and retinal micro-vessel features. Between-group differences (endometriosis vs controls) will be analysed. Associations with blood inflammation markers will be assessed, and changes after treatment will be evaluated.
Data handling and confidentiality Study data are recorded in a case report form and entered into a secure REDCap database hosted by the University of Edinburgh. Personal details (e.g., contact information) are stored separately on secure systems with restricted access. Research data are pseudonymised using study ID codes. Data are retained and archived according to University/NHS Sponsor policies and UK data-protection law. Selected anonymised data and samples may be shared with academic or industry partners as described in the consent documents. Participation is voluntary, and participants may withdraw at any time; data collected up to withdrawal are retained for scientific and regulatory integrity.
Oversight and approvals The study is co-sponsored by the University of Edinburgh and NHS Lothian (ACCORD) and conducted in line with Good Clinical Practice (GCP) and all required approvals. Monitoring or audit may occur according to Sponsor procedures. The study ends after the last participant's last visit; a summary will be provided to the Research Ethics Committee.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (10 listed)
- Participants with a previous surgical or imaging diagnosis of endometriosis
- Healthy volunteers
Key exclusion criteria (27 listed)
- Participants with a previous surgical or imaging diagnosis of endometriosis
- Healthy volunteers
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
Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline
OCT-A-based vessel density (non-invasive angiography) used to characterize retinal microvasculature for baseline between-group comparison. Unit of Measure: percent (%).
10 secondary outcomes
Change from Baseline in Choroidal Thickness
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. What IPD: De-identified participant-level datasets and surplus biological samples as applicable. With Whom/Conditions: Academic or industry partners, as described in the PIS/consent; no release of identifiable data; publications contain no personal data. How/Where: Secure transfer under data-sharing agreements; data stored in validated REDCap with controlled access.
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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.
Andrew Horne principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Edinburgh at 1 site in United Kingdom.
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 10 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Kexin Dong (+447301394870, K.Dong-2@sms.ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS) (time frame: Baseline). The study lists 5 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 21 Oct 2026.