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MD-clip trial


- candidate number25524
- NTR NumberNTR6126
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2016
- Secondary IDsOVI141516 Ergra Low Vision
- Public TitleMD-clip trial
- Scientific TitleThe effect of enhanced prism spectacles on Quality of Life in patients with severe macular degeneration, a Randomized Controlled Trial.
- ACRONYMMD-clip
- hypothesis- 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
- Healt Condition(s) or Problem(s) studiedMacular degeneration
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate31-dec-2016
- Target number of participants160
- InterventionsThe experimental groups wears the MD-clip 3 weeks, the control group receive the MD-Clip after the study
- Primary outcomeThe primary outcome was quality of life as measured with the subscale distance activities and the composite scale of the NEI-VFQ-25
- Secondary outcomeSecondary 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
- Timepointsbaseline, and six weeks after initial visit.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc Martijn Visser
- CONTACT for SCIENTIFIC QUERIESMSc Martijn Visser
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Revoir Group, Ergra Low Vision
- PublicationsVisser MS, Dieleman M, Klijn S, Timman R, Lundström M, Busschbach JJV & Reus NJ. Validation, test-retest reliability and norm scores for the Dutch Catquest-9SF. Acta Ophthalm. 2016;Oct 24. doi: 10.1111/aos.13287.
- Brief summaryOn 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.
- Main changes (audit trail)
- RECORD11-nov-2016 - 3-jan-2017


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