Age-related macular degeneration (AMD) and neovascular age-related macular degeneration (nAMD) Eye Diseases
Conditions
Interventions
Current interventions as of 05/08/2019:
This study will evaluate three self monitoring vision tests
a paper booklet and two vision test software applications (MultiBit test and MyVisionTrack®) that run on an iPod touch.
Approximately =400 participants will be recruited from 5 hospitals who will b
Sponsors
The Queen's University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 05/08/2019: 1. Aged =50 years old 2. At least one eye meeting ALL the inclusion criteria for a study eye 2.1. Eye first treated for active nAMD = 6 months ago 2.2. Eye first treated for active nAMD not more than 42 months ago 2.3. Eye currently being monitored for nAMD disease by the NHS Previous participant inclusion criteria: 1. Patients =50 years old diagnosed with active nAMD (= 6 months earlier) and currently being treated with an anti-VEGF drug or monitored (i.e. with active or inactive nAMD) by the NHS 2. Within 42 months of first treatment for nAMD
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 05/08/2019: 1. Vision in the eye being monitored limited by another eye condition 2. Surgery in the study eye in the previous 6 months 3. Refractive error in the eye being monitored >-6D 4. Retinal or choroidal neovascularization in the eye being monitored not due to nAMD 5. Inability to do one or more of the proposed tests as assessed during ‘further information and training’ session 6. Unable to understand English 7. Unable to comply with proposed home testing 8. Vision is worse than Snellen score 6/60, LogMar 1.04 or 33 letters Previous participant exclusion criteria: 1. Vision in the eye being monitored limited by another eye condition 2. Surgery in the study eye in the previous 6 months 3. Refractive error in the eye being monitored >-6D 4. Retinal or choroidal neovascularization in the eye being monitored not due to nAMD 5. Inability to do one or more of the proposed tests as assessed during ‘further information and training’ session 6. Unable to understand English 7. Unable to comply with proposed home testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is classification of a study eye at a visit as having active or inactive disease. For the reference classification, this is the reviewing ophthalmologist’s decision at a monitoring visit about the activity status of the eye being monitored (definitely active, definitely inactive, ambiguous). Data will also be collected on whether an injection is ordered/given, though this may not correlate perfectly with classification by lesion activity as (a) a patient may decide to refuse further injections or a patient’s health may preclude it or (b) an injection may be given when a lesion is inactive, e.g. in the context of a treat-and-extend regimen. For the index texts, alternative criteria for classification will be explored to maximise test performance. Participants will complete home monitoring tests and routine hospital follow-up for at least 12 months (from consent until the end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/08/2019: 1. The acceptability of the tests to patients and carers and their adherence to home monitoring testing regimens, measured using interviews in their homes and by telephone or Skype 2. Inequalities in recruitment to the study (e.g. age, sex, social economic status and visual acuity in the better-seeing eye at diagnosis) and their impact on the ability of participants to do the tests during follow-up and the adherence of participants to weekly testing 3. Provide pilot data for the use of home monitoring to detect conversion to nAMD in the fellow eyes of patients with unilateral disease, compared to the reference standard of detection of conversion during hospital follow-up with EDTRS visual acuity and OCT imaging. Previous secondary outcome measures: 1. The acceptability of the tests to patients and carers and their adherence to home monitoring testing regimens, measured using interviews in their homes and by telephone or Skype 2. Inequalities in recruitment to the study (e.g. age, sex, social economic status and visual acuity in the better-seeing eye at diagnosis) and their impact on the ability of participants to do the tests during follow-up and the adherence of participants to weekly testing | — |
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactRuth Hogg
Outcome results
None listed