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Not yet recruitingNCT07767058MIND'S EYEUpdated Aug 28, 2026

Mindfulness for Central Serous Chorioretinopathy

An interventional study of Mindfulness in Central Serous Chorioretinopathy, sponsored by King's College Hospital NHS Trust. Not yet recruiting at 6 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary goal of this clinical trial is to test whether a mindfulness-based treatment is effective at shortening the duration of, and improving the features of, central serous chorioretinopathy in adults. Researchers will compare adults with central serous chorioretinopathy who undertake an 8 week mindfulness-based treatment course, with those who do no mindfulness, to see if mindfulness improves time to disease resolution and disease features.

The secondary goal of this clinical trial is to compare adults with central serous chorioretinopathy to adults with healthy eyes across a variety of stress-related factors, and also measure the change in some of these factors, if any, caused by mindfulness.

The questions this clinical trial aims to answer are:

  • is mindfulness effective at improving the clinical course of central serous chorioretinopathy?
  • is a mindfulness-based treatment programme for central serous chorioretinopathy acceptable to adults with the disease?
  • if effective, does mindfulness alter any stress-related psychological or biological features in adults with central serous chorioretinopathy?
  • what are the stress-related psychological and biological features of adults with central serous chorioretinopathy, compared to adults with healthy eyes?

Participants will:

  • Undertake daily mindfulness practices for 8 weeks and participate in fortnightly group sessions, or undertake no mindfulness
  • Visit the research clinic once every month for the first six months, and then again at 12 months, for checkups and tests
02

Conditions studied

  • Central Serous Chorioretinopathy

Keywords

  • central serous chorioretinopathy
  • mindfulness
  • pilot clinical trial
  • stress
03

In context

Central Serous Chorioretinopathy

84 studies on the registry are indexed under Central Serous Chorioretinopathy; 14 are open to participants now.

This study's planned enrollment of 100 is above the median of 35 across 60 interventional studies indexed under Central Serous Chorioretinopathy.

Browse Central Serous Chorioretinopathy studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.

Browse King's College Hospital NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

CSCR Cases:

  1. Adults (> 18 years old)
  2. Active fovea-involving CSCR

  3. Both of the following major diagnostic criteria*:

    1. Presence of SRF within the central 1mm subfield (circular zone of 1mm diameter centred on the foveal umbo) on OCT scan
    2. At least 1 area of RPE alteration on fundus autofluorescence, OCT or infrared imaging

  4. Any one of the following minor diagnostic criteria*:

    1. Sub-foveal choroidal thickness ≥ 400 µm on OCT
    2. ≥ 1 focal leak on FFA
    3. Mid-phase hyperfluorescent placoid areas on ICGA
  5. First episode or a distinct recurrent episode
  6. Duration of current episode \< 180 days

  7. No other cause for the above findings (e.g. diabetic retinopathy, exudative age-related macular degeneration, or polypoidal choroidal vasculopathy)

    • Inclusion criteria based on the Central Serous Chorioretinopathy International Group diagnostic criteria for idiopathic CSCR.13 According to these criteria, an FFA and ICG are not required for diagnosis if choroidal thickness on OCT is ≥ 400 µm. Therefore, review OCT before performing FFA and/or ICGA.

Non-CSCR Cases:

  1. Adults (> 18 years old)
  2. Approximately age- and sex-matched to CSCR cases
  3. No CSCR
  4. No other BCVA-affecting ocular disease or condition

Exclusion criteria

EXCLUSION CRITERIA:

Study eye:

  1. Any treatment for current or previous CSCR with PDT or laser
  2. Use of any topical medication for CSCR currently, or in the last 90 days
  3. Use of topical or carbonic anhydrase inhibitors currently, or in the last 90 days
  4. Intraocular anti-VEGF therapy in the last 180 days
  5. Intraocular steroids in the last 180 days or intraocular steroid implant in the last 3 years
  6. Treatment with retinal or macular laser at any point (except peripheral laser retinopexy at least 90 days prior)
  7. Cryotherapy within 90 days
  8. Previous cyclodiode therapy at any point
  9. Laser refractive surgery within 90 days
  10. Intraocular surgery within 90 days
  11. Presence of any other disease that could cause retinal or SRF (e.g. diabetic retinopathy, exudative age-related macular degeneration, or polypoidal choroidal vasculopathy)
  12. Current or prior retinal or choroidal neovascularisation of any cause
  13. Diabetic retinopathy
  14. Presence of any other disease which is thought to be currently affecting BCVA, or likely to do so during study participation

  15. Media opacity precluding fundus examination and/or imaging (e.g. dense cataract)

    General:

  16. Current, recent (within 90 days) or anticipated (during study participation) treatment with systemic anti-VEGF therapy, oral/intravenous/intramuscular steroids, systemic carbonic anhydrase inhibitors or systemic hormone therapy (except hormonal )
  17. Current or recent (within 90 days) practice of regular (more than twice per week) meditation or mindfulness
  18. Unable, unwilling or unlikely to undertake study activities
  19. Any condition which, in the opinion of the investigator, would prevent the participant from granting or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease

Where potential CSCR participants present with both eyes meeting the above criteria, one eye only will be included in the study. The eye with the greatest central 1 mm subfield thickness (µm) on OCT imaging will be the study eye. In these participants, data on the fellow affected eye in the study will still be collected, to allow the possibility of looking at the symmetry of outcomes between eyes of an individual but will not be included in formal statistical analysis.

For non-CSCR participants, only one eye will be included in the study. Where potential non-CSCR participants present with both eyes meeting the above criteria, the study eye will be chosen at random by last digit of their day of birth, with even numbers including 0 corresponding to right eye and odd numbers corresponding to left eye (e.g. DOB 31/12/1960 = left eye).

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Mindfulness

    The intervention consists of consists of an 8-week self-directed daily mindfulness course, combined with fortnightly group mindfulness sessions that participants are encouraged to join from enrolment up until their month 6 follow up visit. The intervention has been designed specifically for this trial and is tailored to central serous chorioretinopathy. Participants will be given a set of video and audio guidance for daily mindfulness-based practices, for a total duration of 8 weeks, alongside a 'road map' of the intervention to prompt them to which practices to use on each day. Daily practices will include body scan exercises, breathing exercises, mindful movement, mindful moments in daily life exercises, and mindfulness in response to stress exercises. Practices will range from 5 - 20 minutes' duration. Participants will be invited to join fortnightly group mindfulness calls, held via Microsoft Teams, for the first six months of their involvement in the trial.

    Behavioral: Mindfulness

  • No intervention
    No mindfulness

    This is the control group. They will not undertake daily mindfulness practices or fortnightly group sessions.

  • No intervention
    No central serous chorioretinopathy (healthy eyes)

    This arm is the case-control comparator, consisting of age- and sex-matched adults with no central serous chorioretinopathy or other sight-threatening eye conditions

Interventions

  • BehavioralMindfulness

    The intervention is an 8 week course of daily mindfulness practices, accompanied by 6 months of fortnightly group sessions. Two introductory videos will explain about central serous chorioretinopathy, mindfulness and the links both have to stress-related factors, and outline the structure of the mindfulness course. Participants will be given a set of video and audio files that will guide them through daily mindfulness practices, for a total duration of 8 weeks. Daily practices will include body scan exercises, breathing exercises, mindful movement, mindful moments in daily life exercises, and mindfulness in response to stress exercises. Individual practices will range from 5 - 20 minutes' duration. There will also be fortnightly group mindfulness sessions, facilitated by a mindfulness coach and with an Ophthalmologist present. They will include guided mindfulness practices and free discussion time for participants to share their experience of the intervention and ask questions.

06

What researchers measure

Primary outcomes

  1. Time to disease resolution (days), defined as the absence of foveal centrepoint subretinal fluid (SRF) on optical coherence tomography (OCT) imaging, without treatment with either photodynamic therapy (PDT) or laser.

    Time frame: From enrolment until 6 months

Secondary outcomes

  1. Change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letter score)

    Time frame: From baseline to month 2, 6 and 12

  2. Change in 'real world' visual acuity (VA; ETDRS letter score), measured with the patient's usual refractive correction

    Time frame: From baseline to month 2, 6 and 12

  3. Change in low luminance visual acuity (ETDRS letter score)

    Time frame: From baseline to month 2, 6 and 12

  4. Change in maximum subretinal fluid (SRF) height (µm) at any given macular location

    Time frame: From baseline to month 2, 6 and 12

  5. Change in central 1mm subfield thickness (µm)

    Time frame: From baseline to month 2, 6 and 12

  6. Area under the curve of 'real world' VA (ETDRS letter score)

    Time frame: From baseline to month 12

  7. Area under curve of maximum SRF height (µm) at any given macular location

    Time frame: From baseline to month 12

  8. Area under the curve of central 1 mm subfield thickness (µm)

    Time frame: From baseline to month 12

  9. Disease resolution, as defined in the primary outcome (%)

    Time frame: From baseline to month 2, 6 and 12

  10. Treatment of central serous chorioretinopathy (CSCR) with either photodynamic therapy (PDT) or laser (%)

    Time frame: From baseline to month 6 and 12

  11. Re-emergence of CSCR (defined as in the inclusion criteria) in those achieving the primary outcome (%)

    Time frame: From baseline to month 6 and 12

  12. Change in Perceived Stress Questionnaire Index (PSQ Index score; composite score)

    30 item questionnaire. Raw score first calculated. (Raw score - 30) / 90 = PSQ Index (always a value between 0 and 1). Higher scores indicate higher levels of perceived stress.

    Time frame: From baseline to month 2, 6 and 12

  13. Change in Global Pittsburgh Sleep Quality Index Score (PSQI; composite score)

    19 item questionnaire. Score range 0 - 21; 0 = good sleep quality; score \> 5 is standardised clinical threshold for poor sleep quality.

    Time frame: From baseline to month 2, 6 and 12

  14. Change in Patient Health Questionnaire-9 score (PHQ-9; composite score)

    9 item questionnaire. Score range 0 - 27; severity of depressive symptoms: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe).

    Time frame: From baseline to month 2, 6 and 12

  15. Change in Generalised Anxiety Disorder-7 score (GAD-7; composite score)

    7 item questionnaire. Score range 0 - 21; 0-4 Minimal anxiety, 5-9 Mild anxiety, 10-14 Moderate anxiety, 15-21 Severe anxiety.

    Time frame: From baseline to month 2, 6 and 12

  16. Change in serum total cholesterol (mmol/L)

    Time frame: From baseline to month 2

  17. Change in serum pre-10am cortisol (nmol/L)

    Time frame: From baseline to month 2

  18. Change in serum testosterone (nmol/L)

    Time frame: From baseline to month 2

  19. Change in serum progesterone (nmol/L)

    Time frame: From baseline to month 2

  20. Change in serum oestradiol (pmol/L)

    Time frame: From baseline to month 2

  21. Change in serum follicle stimulating hormone (FSH; IU/L)

    Time frame: From baseline to month 2

  22. Change in serum luteinising hormone (LH; IU/L)

    Time frame: From baseline to month 2

  23. Change in serum angiotensin converting enzyme (ACE; U/L)

    Time frame: From baseline to month 2

  24. Change in urine 24-hour cortisol (nmol/24hr)

    Time frame: From baseline to month 2

  25. Change in urine serotonin (µg/g Crea)

    Time frame: From baseline to month 2

  26. Change in urine dopamine (µg/g Crea)

    Time frame: From baseline to month 2

  27. Change in urine noradrenaline (NA; µg/g Crea)

    Time frame: From baseline to month 2

  28. Change in urine adrenaline (Adr; µg/g Crea)

    Time frame: From baseline to month 2

  29. Change in urine NA/Adr ratio

    Time frame: From baseline to month 2

  30. Area under the curve of saliva cortisol awakening response (ng/ml)

    Saliva cortisol awakening response is measured with four samples of saliva taken immediately upon waking, and 15/30/60 after waking.

    Time frame: From baseline to month 2

  31. Area under the curve of saliva cortisol diurnal variation (ng/ml)

    Saliva diurnal variation is measured with four saliva samples, taken at 60 minutes after waking, 12pm, 4pm and 8pm.

    Time frame: From baseline to month 2

  32. Change in systolic blood pressure (mmHg)

    Time frame: From baseline to month 2

  33. Change in diastolic blood pressure (mmHg)

    Time frame: From baseline to month 2

  34. Change in maximum choroidal thickness (µm) at any given macular location

    Time frame: From baseline to month 2

  35. Area under the curve of maximum choroidal thickness (µm) at any given macular location

    Time frame: From baseline to month 12

  36. Change in National Eye Institute Visual Function Questionnaire-25 score (VFQ-25; composite score)

    25 item questionnaire. Score range 0 - 100. Higher scores indicate better visual function.

    Time frame: From baseline to month 2, 6 and 12

Other outcomes

  1. Macular Treatment Satisfaction Questionnaire score (MacTSQ; composite score)

    Feasibility outcome measure. 12-14 item questionnaire. Score range 0 - 72. Score of 60 or higher indicate high treatment satisfaction.

    Time frame: From baseline to month 2

  2. Descriptive feedback from participants on their experience of the intervention

    Feasibility outcome measure. Descriptive, qualitative, verbal interview format, no validated scale to be used, descriptive information will be gathered from participants at month 2 visit on their experience of the intervention.

    Time frame: From baseline to month 2

  3. Number of participants recruited per site per month

    Feasibility outcome measure.

    Time frame: From the time of green lighting of the first study site, up until the point at which the last patient is recruited on to the study, projected to be approximately 45 months.

  4. Cost (£) of intervention

    Feasibility outcome measure. Cost associated with developing and delivering the mindfulness intervention: development by neuro-ophthalmologist, mindfulness coach to lead group sessions, ophthalmologist to facilitate group sessions, other costs that arise during course of intervention not previously foreseen

    Time frame: From the study start date through to study completion, projected to be around 45 months

  5. Adherence to daily mindfulness intervention (%)

    Feasibility outcome measure. Measured in intervention (mindfulness) group only.

    Time frame: From baseline to month 2.

  6. Attrition (%) at study end

    Feasibility outcome measure.

    Time frame: From baseline to month 12

  7. Estimation of costs (£) associated with intervention to potential future provider organisations

    Feasibility outcome measure. Description of costs estimated to be involve in expansion of intervention to general NHS eye services.

    Time frame: From study start to study end

  8. Participants in the no mindfulness control group (%) that report undertaking mindfulness practices more than twice per week during the study

    Feasibility outcome measure

    Time frame: From baseline to month 2

  9. Adverse events (Medical Dictionary for Regulatory Activities [MedDRA] preferred terms)

    Safety outcome measure (descriptive, qualitative and quantitative)

    Time frame: From baseline to month 12

  10. Difference in mean Dimensional Assessment of Personality Pathology - Short Form score between CSCR and non-CSCR cases (DAPP-SF, composite score)

    Case control outcome. 136 item questionnaire.

    Time frame: At baseline

  11. Difference in mean HEXACO Personality Inventory - Revised score between CSCR and non CSCR cases (HEXACO PI-R; composite score)

    Case control outcome. 100 item questionnaire. Individual items scored from 1 (strongly disagree) to 5 (strongly agree). Mean scores calculated for each personality facet. Some items are reverse-scored. Full details provided open access online at www.hexaco.org. Final mean score calculated from means of all facets.

    Time frame: At baseline

  12. Difference in mean Holmes-Rahe Life Stress Inventory score between CSCR and non CSCR cases (composite score)

    Case control outcome. 43 item questionnaire. Each item has a specific point value. Total score = sum of all point values for selected items. Score range 0 to 300+; 0 - 149 Low susceptibility to stress-induced health breakdown, 150 - 299 Around 50% chance of major stress-induced health breakdown in next two years, 300+ Around 80% chance of major stress-induced health breakdown in next two years.

    Time frame: At baseline

  13. Difference in mean PSQ Index score between CSCR and non CSCR cases (composite score)

    Case control outcome. 30 item questionnaire. Raw score first calculated. (Raw score - 30) / 90 = PSQ Index (always a value between 0 and 1). Higher scores indicate higher levels of perceived stress.

    Time frame: At baseline

  14. Difference in mean Global PSQI Score between CSCR and non CSCR cases (composite score)

    Case control outcome. 19 item questionnaire. Score range 0 - 21; 0 = good sleep quality; score \> 5 is standardised clinical threshold for poor sleep quality.

    Time frame: At baseline

  15. Difference in mean PHQ-9 score between CSCR and non CSCR cases (composite score)

    Case control outcome. 9 item questionnaire. Score range 0 - 27; severity of depressive symptoms: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe).

    Time frame: At baseline

  16. Difference in mean GAD-7 score between CSCR and non CSCR cases (composite score)

    Case control outcome. 7 item questionnaire. Score range 0 - 21; 0-4 Minimal anxiety, 5-9 Mild anxiety, 10-14 Moderate anxiety, 15-21 Severe anxiety.

    Time frame: At baseline

  17. Difference in mean serum total cholesterol between CSCR and non CSCR cases (mmol/L)

    Case control outcome

    Time frame: At baseline

  18. Difference in mean serum pre-10am cortisol between CSCR and non CSCR cases (nmol/L)

    Case control outcome

    Time frame: At baseline

  19. Difference in mean serum testosterone between CSCR and non CSCR cases (nmol/L)

    Case control outcome

    Time frame: At baseline

  20. Difference in mean serum progesterone between CSCR and non CSCR cases (nmol/L)

    Case control outcome

    Time frame: At baseline

  21. Difference in mean serum oestradiol between CSCR and non CSCR cases (pmol/L)

    Case control outcome

    Time frame: At baseline

  22. Difference in mean serum FSH between CSCR and non CSCR cases (IU/L)

    Case control outcome

    Time frame: At baseline

  23. Difference in mean serum LH between CSCR and non CSCR cases (IU/L)

    Case control outcome

    Time frame: At baseline

  24. Difference in mean serum ACE between CSCR and non CSCR cases (U/L)

    Case control outcome

    Time frame: At baseline

  25. Difference in mean urine 24-hour cortisol between CSCR and non CSCR cases (nmol/24hr)

    Case control outcome

    Time frame: At baseline

  26. Difference in mean urine serotonin between CSCR and non CSCR cases (µg/g Crea)

    Case control outcome

    Time frame: At baseline

  27. Difference in mean urine dopamine between CSCR and non CSCR cases (µg/g Crea)

    Case control outcome

    Time frame: At baseline

  28. Difference in mean urine NA between CSCR and non CSCR cases (µg/g Crea)

    Case control outcome

    Time frame: At baseline

  29. Difference in mean urine Adr between CSCR and non CSCR cases (µg/g Crea)

    Case control outcome

    Time frame: At baseline

  30. Difference in mean urine NA/Adr ratio between CSCR and non CSCR cases

    Case control outcome

    Time frame: At baseline

  31. Difference in mean area under the curve of saliva cortisol awakening response between CSCR and non CSCR cases (ng/ml)

    Case control outcome. Saliva cortisol awakening response is measured with four samples of saliva taken immediately upon waking, and 15/30/60 after waking.

    Time frame: At baseline

  32. Difference in mean area under the curse of saliva cortisol diurnal variation between CSCR and non CSCR cases (ng/ml)

    Case control outcome. Saliva diurnal variation is measured with four saliva samples, taken at 60 minutes after waking, 12pm, 4pm and 8pm.

    Time frame: At baseline

  33. Difference in mean systolic blood pressure between CSCR and non CSCR cases (mmHg)

    Case control outcome

    Time frame: At baseline

  34. Difference in mean diastolic blood pressure between CSCR and non CSCR cases (mmHg)

    Case control outcome

    Time frame: At baseline

  35. Difference in mean maximum choroidal thickness at any given macular location between CSCR and non CSCR cases (µm)

    Case control outcome

    Time frame: At baseline

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jul 2030, 45 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Aug 17, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2030
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767058
Lead sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Aug 28, 2026

Study contacts

Olivia Cundy, BA, BMBCh
Contact
olivia.cundy@nhs.net
02032997791
King's Ophthalmology Research Unit
Contact
kch-tr.ophthalmologyresearch@nhs.net
Timothy Jackson
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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