Central Serous Chorioretinopathy
Conditions
Keywords
central serous chorioretinopathy, mindfulness, pilot clinical trial, stress
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
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.
Sponsors
King's College Hospital NHS Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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 steroids 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 contraception) 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 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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Area under the curve of 'real world' VA (ETDRS letter score) | From baseline to month 12 | — |
| Area under curve of maximum SRF height (µm) at any given macular location | From baseline to month 12 | — |
| Area under the curve of central 1 mm subfield thickness (µm) | From baseline to month 12 | — |
| Disease resolution, as defined in the primary outcome (%) | From baseline to month 2, 6 and 12 | — |
| Treatment of central serous chorioretinopathy (CSCR) with either photodynamic therapy (PDT) or laser (%) | From baseline to month 6 and 12 | — |
| Re-emergence of CSCR (defined as in the inclusion criteria) in those achieving the primary outcome (%) | From baseline to month 6 and 12 | — |
| Change in Perceived Stress Questionnaire Index (PSQ Index score; composite score) | 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. |
| Change in Global Pittsburgh Sleep Quality Index Score (PSQI; composite score) | 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. |
| Change in Patient Health Questionnaire-9 score (PHQ-9; composite score) | 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). |
| Change in Generalised Anxiety Disorder-7 score (GAD-7; composite score) | 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. |
| Change in serum total cholesterol (mmol/L) | From baseline to month 2 | — |
| Change in serum pre-10am cortisol (nmol/L) | From baseline to month 2 | — |
| Change in serum testosterone (nmol/L) | From baseline to month 2 | — |
| Change in serum progesterone (nmol/L) | From baseline to month 2 | — |
| Change in serum oestradiol (pmol/L) | From baseline to month 2 | — |
| Change in serum follicle stimulating hormone (FSH; IU/L) | From baseline to month 2 | — |
| Change in serum luteinising hormone (LH; IU/L) | From baseline to month 2 | — |
| Change in serum angiotensin converting enzyme (ACE; U/L) | From baseline to month 2 | — |
| Change in urine 24-hour cortisol (nmol/24hr) | From baseline to month 2 | — |
| Change in urine serotonin (µg/g Crea) | From baseline to month 2 | — |
| Change in urine dopamine (µg/g Crea) | From baseline to month 2 | — |
| Change in urine noradrenaline (NA; µg/g Crea) | From baseline to month 2 | — |
| Change in urine adrenaline (Adr; µg/g Crea) | From baseline to month 2 | — |
| Change in urine NA/Adr ratio | From baseline to month 2 | — |
| Area under the curve of saliva cortisol awakening response (ng/ml) | 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. |
| Area under the curve of saliva cortisol diurnal variation (ng/ml) | From baseline to month 2 | Saliva diurnal variation is measured with four saliva samples, taken at 60 minutes after waking, 12pm, 4pm and 8pm. |
| Change in systolic blood pressure (mmHg) | From baseline to month 2 | — |
| Change in diastolic blood pressure (mmHg) | From baseline to month 2 | — |
| Change in maximum choroidal thickness (µm) at any given macular location | From baseline to month 2 | — |
| Area under the curve of maximum choroidal thickness (µm) at any given macular location | From baseline to month 12 | — |
| Change in National Eye Institute Visual Function Questionnaire-25 score (VFQ-25; composite score) | From baseline to month 2, 6 and 12 | 25 item questionnaire. Score range 0 - 100. Higher scores indicate better visual function. |
Countries
United Kingdom
Contacts
CONTACTOlivia Cundy, BA, BMBCh
CONTACTKing's Ophthalmology Research Unit
PRINCIPAL_INVESTIGATORTimothy Jackson
King's College London
Outcome results
None listed