Mindfulness for Central Serous Chorioretinopathy

NCT07767058 | Not Yet Recruiting

• 1 other identifier: IRAS 374706
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Central Serous Chorioretinopathy

Keywords

central serous chorioretinopathy; mindfulness; pilot clinical trial; stress

Outcome Measures

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.

  From enrolment until 6 months

Secondary Outcomes (36)

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

  From baseline to month 2, 6 and 12

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

  From baseline to month 2, 6 and 12

• Change in low luminance visual acuity (ETDRS letter score)

  From baseline to month 2, 6 and 12

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

  From baseline to month 2, 6 and 12

• Change in central 1mm subfield thickness (µm)

  From baseline to month 2, 6 and 12

Other Outcomes (35)

• Macular Treatment Satisfaction Questionnaire score (MacTSQ; composite score)

  From baseline to month 2

• Descriptive feedback from participants on their experience of the intervention

  From baseline to month 2

• Number of participants recruited per site per month

  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.

Study Arms (3)

Mindfulness

EXPERIMENTAL

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 mindfulness

NO INTERVENTION

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

No central serous chorioretinopathy (healthy eyes)

NO INTERVENTION

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

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.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CSCR Cases:
• Adults (\> 18 years old)
• Active fovea-involving CSCR
• Both of the following major diagnostic criteria\*:
• Presence of SRF within the central 1mm subfield (circular zone of 1mm diameter centred on the foveal umbo) on OCT scan
• At least 1 area of RPE alteration on fundus autofluorescence, OCT or infrared imaging
• Any one of the following minor diagnostic criteria\*:
• Sub-foveal choroidal thickness ≥ 400 µm on OCT
• ≥ 1 focal leak on FFA
• Mid-phase hyperfluorescent placoid areas on ICGA
• First episode or a distinct recurrent episode
• Duration of current episode \< 180 days
• No other cause for the above findings (e.g. diabetic retinopathy, exudative age-related macular degeneration, or polypoidal choroidal vasculopathy)
• Non-CSCR Cases:
• Adults (\> 18 years old)

You may not qualify if:

• 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 at any point (except peripheral laser retinopexy at least 90 days prior)
• Cryotherapy within 90 days
• Previous cyclodiode therapy at any point
• Laser refractive surgery within 90 days
• Intraocular surgery within 90 days
• Presence of any other disease that could cause retinal or SRF (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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (6)

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

Clinical Eye Research Centre, St Paul's Eye Unit, Liverpool University Hospitals NHS Trust

Liverpool, L7 8YE, United Kingdom

Location

King's College London Frost Eye Departent, Guys' and St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Hillingdon Hospital

London, UB8 3NN, United Kingdom

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Timothy Jackson

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Cundy, BA, BMBCh

CONTACT

02032997791; olivia.cundy@nhs.net

King's Ophthalmology Research Unit

CONTACT

kch-tr.ophthalmologyresearch@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and clinical investigators will not be masked, due to the nature of the intervention. Visual acuity assessors, imaging technicians, laboratory scientists and reading centre imaging assessors will all be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial contains two models - an interventional model and a case-control model. The primary model is a parallel interventional model involving two arms (intervention and control) of participants, both of which have central serous chorioretinopathy. The secondary model is a case control model involving the two groups of participants with central serous chorioretinopathy, and another group of participants with healthy eyes. As such, the investigators have entered 3 total arms to the trial in the section below, but only two of these arms are part of the interventional element of the trial.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)