Mindfulness for Central Serous Chorioretinopathy

N/ANot Yet RecruitingNCT07767058

King's College Hospital NHS Trust100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Central Serous Chorioretinopathy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

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

Time frame: 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

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

Change in low luminance visual acuity (ETDRS letter score)

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

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

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

Change in central 1mm subfield thickness (µm)

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

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

Time frame: From baseline to month 12

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

Time frame: From baseline to month 12

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

Time frame: From baseline to month 12

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

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

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

Time frame: From baseline to month 6 and 12

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

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

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

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

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

Change in serum total cholesterol (mmol/L)