Mindfulness for Central Serous Chorioretinopathy
ConditionCentral Serous Chorioretinopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults (> 18 years old)
Active fovea-involving CSCR
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: MindfulnessExperimental treatment 1 intervention
Group B: No mindfulnessNo intervention 0 interventions
Group C: No central serous chorioretinopathy (healthy eyes)No intervention 0 interventions
Trial outcomes
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 monthsSecondary 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 122
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 123
Change in low luminance visual acuity (ETDRS letter score)
Time frame
From baseline to month 2, 6 and 124
Change in maximum subretinal fluid (SRF) height (µm) at any given macular location
Time frame
From baseline to month 2, 6 and 12Other 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 22
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 23
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov
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