VitroCap N (Ebiga Vision, Germany), a supplement for eye health, has been approved by the Therapeutic Goods Administration (TGA) for sale in Australia.
In a clinical trial,1 the supplement, which has an active formulation of antioxidative and antiglycation micronutrients, was used by patients with vitreous floaters. The patients self-reported “significant improvement in contrast sensitivity… following supplementation”, compared with the placebo group, which reported no significant change.
Floaters occur with ageing and/or disease when the vitreous humour in the posterior segment of the human eye, which contributes to intraocular clarity, eyeball shape and intraocular pressure, liquifies and contracts, causing microscopic collagen fibres to clump together and cast shadows over the retina.
Floaters are characterised by “the perception of flies, cobwebs and shadows within the visual field” and usually described as a nuisance, however they can also reduce visual function and health-related quality of life.
Once the possibility of retinal pathology has been ruled out, patients who complain of floaters are often reassured and counselled that their floaters will resolve with time or are encouraged to adapt to their new visual experience.
However, the Floater Intervention Study (FLIES) study, led by PhD candidate Emmanuel Ankamah from Ireland, found that of 61 participants, 17 (27.9%) reported consistently bothersome floaters over six months.
Ninety-six per cent of respondents from the unilateral sub-group and 100% of respondents from the bilateral subgroup reported intermittent to consistent disturbance from floaters over the six-month period.
The activities of reading and using the computer were most affected by floaters.
OUTCOMES OF SUPPLEMENTATION
The FLIES study, a parallel group, single centre double-blind placebo-controlled randomised interventional trial, involved 343 subjects with vitreous floaters of long duration (more than six months).2
Before enrolling, prospective participants underwent a complete ophthalmic examination, including scanning laser ophthalmoscopy video imaging of the vitreous to detect floaters. To elicit the health-related quality of life associated with vitreous floaters alone, 282 subjects with other ocular co-morbidities were excluded from the study.
The investigators analysed the impact of supplementation with VitroCap N or placebo for six months.
They assessed patients’ change in visual discomfort from floaters, with the Floater Disturbance Questionnaire. Additionally, they measured secondary outcomes including best-corrected visual acuity, letter contrast sensitivity, photopic functional contrast sensitivity with positive and negative contrast polarity, and quantitative vitreous opacity areas.
The study found “improvements in vision-related quality of life and visual function of patients suffering from vitreous floaters after supplementation with a formulation of antioxidative and antiglycation micronutrients”. The paper noted that the improvements were confirmed by the decrease in vitreous opacity areas in the active group.
They reported that “after supplementation, the active group had a significant decrease in their visual discomfort from floaters (P < 0.001), whereas the placebo group had no significant change in their visual discomfort (P = 0.416)”.
“At six months, there was a significant decrease in vitreous opacity areas in the active group (P < 0.001) and an insignificant increase in vitreous opacity areas in the placebo group (P = 0.081).”
Following the publication of the positive outcomes of the FLIES study, the Australian company Stiltec has secured distribution rights for the patented VitroCap brand and formulation in several markets including Australia and New Zealand.
As with all other Stiltec products, VitroCap will only be promoted to eye health professionals.
References
- Floater Intervention Study (FLIES): supplementation trial for the reduction of visual disturbances associated with vitreous floaters. ISRCTN15605916. DOI: 10.1186/ISRCTN15605916.
- Ankamah, W., Green-Gomez, M., Kaercher, and Nolan J. M., et al., Dietary intervention with a targeted micronutrient formulation reduces the visual discomfort associated with vitreous degeneration. Tvst.arvojournals.org October 2021; 10(12):19.
