Mindfulness for Central Serous Chorioretinopathy

A Pilot Randomised Controlled Trial of a Disease-specific Mindfulness-based Therapy 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

INCLUSION CRITERIA:

CSCR Cases:

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

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 (except peripheral laser retinopexy at least 90 days prior)

7. Cryotherapy within 90 days

8. Previous cyclodiode therapy

9. Laser refractive surgery within 90 days

10. Intraocular surgery within 90 days

11. 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)

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 or oral/intravenous/intramuscular steroids

17. Current or recent (within 90 days) practice of regular (more than twice per week) meditation or mindfulness

18. Current or recent (within 90 days) use of systemic carbonic anhydrase inhibitors

19. Unable, unwilling or unlikely to undertake study activities

20. 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.