Age-related macular degeneration Eye Diseases Degeneration of macula and posterior pole
Conditions
Interventions
Patient suitability:
An ocular examination to determine patients? suitability for the See Again assessment, usually 30 minutes duration.
Confirmation from patient?s GP that there is no reason why th
Sponsors
See Again Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The ophthalmic surgeon will select suitable patients 2. Patients with significant stable macular degeneration (dry), ideally with less than two disc diameters of ARMD 3. Patients must have significant lens opacities in the affected eye and a visual acuity of <6/36 4. Patients must have an endothelial cell count greater than 1,600 per square mm in the affected eye 5. Patients must demonstrate a positive screening test result when using the the See Again assessment lens set i.e. exhibit at least a two line improvement when reading the ETDRS Chart
Exclusion criteria
Exclusion criteria: 1. Patients with active ARMD 2. Patients with active ocular inflammation 3. Patients with previous cataract surgery 4. Patients with lack of mental capability to give informed consent 5. Patients with an inability to understand spoken and written English 6. Patients who are involved or have been involved in a research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. An improvement from baseline in the patients final best corrected visual acuity (using ETDRS Chart). An improvement of 2 lines or more will constitute a positive result for a patient. 2. Mean or median improvement values will also be analysed at 3 months. The measures of the independent assessor will be employed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proof of concept secondary outcome measures are 1. Endothelial cell count will be compared to the patient?s baseline. A deterioration of less than 20% will constitute a positive result. 2. Improved mobility of the patient, this will be subjective based on patient response. Any perceived improvement in mobility will constitute a positive result. 3. Improved wellbeing of the patient, this will be subjective based on patient response to navigational capability and dependence on relatives and/or carers. Any perceived improvement in wellbeing will constitute a positive result. If successful, much larger trials will be undertaken in Ireland, UK and France that will define the predictability and reproducibility of performing the implant procedure.The health economics case will be collected from the same group of patients over a longer period (2 years) and will be based based on changes to direct healthcare costs, indirect healthcare costs and care costs in the community. | — |
Countries
United Kingdom
Outcome results
None listed