No registrations found.
ID
Source
Brief title
Health condition
Patients experiencing severe irreversible vision loss as a result of age-related macular degeneration (ARMD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome was quality of life as measured with the subscale distance activities and the composite scale of the NEI-VFQ-25
Secondary outcome
Secondary outcomes were visual acuity (ETDRS) and contrast sensitivity (Pelli-Robson) measures with or with the MD-clip. Burden was measured using the EQ-5D-5L
Background summary
On the long term most patients with age-related macular degeneration (ARMD) will experience severe irreversible vision loss. These low vision patients might benefit from an enhanced spectacle (MD-clip), equipped with several features, such as a prism using the outside of the macula. Experience in daily practice has shown that the MD-clip improves visual functioning. To substantiate these findings, we have undertaken this study to investigate the effect of the MD-clip on quality of life (QOL), particularly when the vision is actually improved. Additionally, we study the vision enhanced by the MD-clip, as well as the burden caused by the disease. In this prospective, open-label, randomized controlled trial, patients were randomized assigned (1:1) to either the MD-clip group or the waiting list.
Study objective
- The enhanced prism spectacle (MD-clip) will increase the Quality of Life in patients with severe macula degeneration
- The MD-clip will increase vision in patients with severe macula degeneration
Study design
baseline, and six weeks after initial visit.
Intervention
The experimental groups wears the MD-clip 3 weeks, the control group receive the MD-Clip after the study
Martijn Visser
PO Box 2040
Rotterdam 3000 CA
The Netherlands
Tel. +31 10 704 38 10
E-Mail m.s.visser@erasmusmc.nl
Martijn Visser
PO Box 2040
Rotterdam 3000 CA
The Netherlands
Tel. +31 10 704 38 10
E-Mail m.s.visser@erasmusmc.nl
Inclusion criteria
- diagnosis of age-related macular degeneration (AMD)
- aged at least 18 years
- signed informed consent.
Exclusion criteria
- insufficient capacities of the Dutch language
- handicaps impeding participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5944 |
| NTR-old | NTR6126 |
| Other | Ergra Low Vision : OVI141516 |