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NCT Number: NCT07767058

Mindfulness for Central Serous Chorioretinopathy

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

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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Eye Hospital, Bristol, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CSCR Cases:

  • Adults (> 18 years old)
  • Active foveal centrepoint-involving CSCR
  • Diagnosis based on history, examination and OCT scan ± FFA
  • Central sub-foveal subretinal fluid on OCT scan
  • First episode or a distinct recurrent episode
  • Duration of current episode < 180 days

Non-CSCR Cases:

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

Exclusion criteria

Study eye:

  • Any treatment for current or previous CSCR with PDT or laser
  • Use of any topical medication for CSCR currently, or in the last 90 days
  • Use of topical steroids or carbonic anhydrase inhibitors currently, or in the last 90 days
  • Intraocular anti-VEGF therapy in the last 180 days
  • Intraocular steroids in the last 180 days or intraocular steroid implant in the last 3 years
  • Treatment with retinal or macular laser (except peripheral laser retinopexy at least 90 days prior)
  • Cryotherapy within 90 days
  • Previous cyclodiode therapy
  • Laser refractive surgery within 90 days
  • Intraocular surgery within 90 days
  • Presence of any other disease that could cause retinal or subretinal fluid (e.g. diabetic retinopathy, exudative age-related macular degeneration, or polypoidal choroidal vasculopathy)
  • Current or prior retinal or choroidal neovascularisation of any cause
  • Diabetic retinopathy
  • Presence of any other disease which is thought to be currently affecting BCVA, or likely to do so during study participation
  • Media opacity precluding fundus examination and/or imaging (e.g. dense cataract)

General:

  • Current, recent (within 90 days) or anticipated (during study participation) treatment with systemic anti-VEGF therapy or oral/intravenous/intramuscular steroids
  • Current or recent (within 90 days) practice of regular (more than twice per week) meditation or mindfulness
  • Current or recent (within 90 days) use of systemic carbonic anhydrase inhibitors
  • Unable, unwilling or unlikely to undertake study activities
  • Any condition which, in the opinion of the investigator, would prevent the participant from granting informed consent 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.

Treatment and study plan

Mindfulness

Behavioral

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.

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)

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

    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.

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

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

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

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

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

    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).

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

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

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

  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)

    Time frame: From baseline to month 2

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

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

    Time frame: From baseline to month 2

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

  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)

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

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

Other outcomes

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

    Time frame: From baseline to month 2

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

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

    Time frame: From baseline to month 2

    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.

  3. Number of participants recruited per site per month

    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.

    Feasibility outcome measure.

  4. Cost (£) of intervention

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

    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

  5. Adherence to daily mindfulness intervention (%)

    Time frame: From baseline to month 2.

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

  6. Attrition (%) at study end

    Time frame: From baseline to month 12

    Feasibility outcome measure.

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

    Time frame: From study start to study end

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

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

    Time frame: From baseline to month 2

    Feasibility outcome measure

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

    Time frame: From baseline to month 12

    Safety outcome measure (descriptive, qualitative and quantitative)

Study contacts

Contact information is provided by the study sponsor or research team.

King's Ophthalmology Research Unit

CONTACT

[email protected]

Olivia Cundy, BA, BMBCh

CONTACT

[email protected]

02032997791

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

A Pilot Randomised Controlled Trial of a Disease-specific Mindfulness-based Therapy for Central Serous Chorioretinopathy

Acronym: MIND'S EYE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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