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NCT04084587
Visual Rehabilitation Through Acoustic Biofeedback With Retimax Vision Trainer in Patients With Advanced Age-related Macular Degeneration
NA trial testing Retimax Vision Trainer in Macular Degeneration Advanced in 24 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | University of Modena and Reggio Emilia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 7 March 2019 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Retimax Vision Trainer
Conditions studied
- Macular Degeneration Advanced — all drugs for Macular Degeneration Advanced →
- Macular Degeneration, Senile — all drugs for Macular Degeneration, Senile →
- Macular Degeneration, Dry — all drugs for Macular Degeneration, Dry →
- Macular Scar — all drugs for Macular Scar →
Sponsor
University of Modena and Reggio Emilia
Who can join
Adults 18 to 90, any sex, with Macular Degeneration Advanced or Macular Degeneration, Senile. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
At present there are no real therapies able to improve visual performance in patients with age-related macular degeneration, atrophic type. The aim of the study is to verify whether with rehabilitation sessions with Retimax Vision Trainer it is possible to teach the maculopathic patient to exploit the extrafoveal areas of the retina, not affected by atrophy, resorting to an eccentric vision that compensates for the foveal one, thus obtaining a improvement of visual outcomes (far and near vision capacity, sensitivity to contrast to reading, reading speed, fixation capacity and overall quality of life of the visually impaired patient suffering from atrophic senile maculopathy (AMD)). To do this, the study design was conceived as a non-randomized prospective comparative and involves the formation of two groups of patients: a group A of 15 patients who will be rehabilitated with Retimax and a group B of 15 patients who will not be rehabilitated, but only re-evaluated at the same distance of time that will elapse for group A. Eligible patients are affected by atrophic AMD with unstable fixation and better vision in the eye between 1/10 and 4/10 in the absence of other serious eye diseases. As there is currently no real therapy capable of improving visual performance, the demonstration of the positive effect of the visual rehabilitation program with Retimax in patients suffering from atrophic macular degeneration may encourage a wider use of this method. The patient could benefit from a non-invasive, repeatable and cost-effective procedure.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Environmental and behavioural interventions for reducing physical activity limitation and preventing falls in older people with visual impairment.
E JY, Li T, McInally L, Thomson K, et al · · 2020 · cited 19× · PMID 32885841 · DOI 10.1002/14651858.cd009233.pub3 -
Efficacy of biofeedback rehabilitation based on visual evoked potentials analysis in patients with advanced age-related macular degeneration.
Verdina T, Piaggi S, Ferraro V, Russolillo V, et al · · 2020 · cited 7× · PMID 33257759 · DOI 10.1038/s41598-020-78076-w
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04084587 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Modena and Reggio Emilia
- Last refreshed: 10 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04084587.
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