Age-related Macular Degeneration Eye Diseases Age-related Macular Degeneration
Conditions
Interventions
Participants randomly allocated to the intervention arm of the study will wear a lightmask each night for 12 months, which provides a dim green light to illuminate the retina through the closed eye li
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants will be aged between 55 and 88 years of age, may be male or female, and will have a corrected ETDRS visual acuity in the test eye of 40 letters (logMAR 0.3, Snellen 6/12) or better. Additional inclusion criteria for participants in the trial: 1. A diagnosis of neovascular AMD in one eye only. Participants will have completed within the past month their initial 3 months of Lucentis ® loading injections, and will be entering a 'treatment as required' regime, based around a 4 weekly schedule of check-ups. Fellow eye will be classified as early AMD, characterised by the presence of soft drusen and/or focal pigmentary changes, in the absence of signs of advanced AMD e.g. retinal oedema, exudates, haemorrhage, geographic atrophy. 2. Participants will need to be willing to adhere to the allocated treatment for the duration of the trial. Additional inclusion criteria for participants in the cross-sectional study: Normal retinal appearance (controls) or grade 1 AMD (according to the AREDS simplified scale).
Exclusion criteria
Exclusion criteria: Any potential participant will be excluded if they have: 1. Ocular pathology other than macular disease, including: non-AMD related fundus changes, narrow anterior angles (=grade 1 van Herrick), amblyopia, significant cataract (LOCS III graded, above grade 2 on any criterion), central corneal/media opacity, any posterior eye condition, glaucoma, history of prodromal symptoms of closed angle glaucoma. 2. Significant systemic disease known to affect visual function (e.g. diabetes, Parkinson?s disease, Alzheimer?s disease). 3. History of medication known to affect visual function (e.g. chloroquine, tamoxifen). 4. An insufficient level of English language comprehension to be able to carry out the questionnaires and monthly interviews with study personnel. 5. A history of falls, or a high risk of falling. Additional exclusion criteria for participants in the trial: 1. A diagnosis of advanced AMD in both eyes. 2. Significant systemic disease that would compromise participation in a 1 year study (e.g. motor neurone disease). 3. Cognitive impairment as determined using an abridged Mini Mental State Examination (Margrain et al. 2012) 4. Oxygen mask worn at night. Additional exclusion criteria for participants in the cross-sectional study: Age-related macular degeneration beyond grade 1 on the AREDS simplified scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are two co-primary outcome measures for the study - one a structural measure of disease progression based on retinal imaging, and one a measure of visual function - which act as surrogate markers for disease progression: 1. The proportion of people who show disease progression in the eye with early AMD during the 12 months of the study based on analysis of retinal images (increase in drusen volume and/or progression to advanced AMD). Increase in drusen volume will be assessed based on Optical Coherence Tomography images taken at baseline and at 12 months. Progression to advanced AMD will be assessed by evaluating medical records at 12 months. 2. The rate of retinal adaptation (time taken for photoreceptors to recover their sensitivity after being exposed to a bright adapting light). This will be measured at baseline and at 12 months, and will also be assessed in participants enrolled in the associated cross-sectional study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in drusen volume over the 12 month follow-up period. This will be measured at baseline, and at monthly appointments throughout the 12 month follow-up period. Drusen volume will also be assessed in participants enrolled in the associated cross-sectional study. 2. The number of Lucentis ® retreatments required during the year in the fellow eye, with nAMD. A review of medical records at the end of 12 months will enable us to quantify the impact of low-level night-time light therapy on the frequency of Lucentis ® retreatment in eyes with active nAMD at baseline. 3. Changes in visual function including colour discrimination thresholds (using the Colour Assessment and Diagnosis Test, City Occupational Ltd.), visual acuity. and psychophysical 14 Hz flicker thresholds. These outcomes will be measured at baseline and at 12 months, and will also be measured in participants enrolled in the associated cross-sectional study. 4. Self-report outcome measures including health related quality-of-life (EQ-5D) and visual function (VFQ-48). This outcome will be measured at baseline and at 12 months. 5. Sleep questionnaire (Pittsburgh Sleep Quality Index, PSQI) and semi structured interviews (conducted monthly by interview) to determine intervention acceptability. This will be measured at baseline, and at monthly appointments throughout the 12 month follow-up period. | — |
Countries
United Kingdom
Outcome results
None listed