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FLIES study

FLIES Study

The Floater Intervention Study (FLIES Study) reports the outcomes of the Floater Intervention Study (FLIES), which was led by the Nutrition Research Centre Ireland (NRCI, Waterford Institute of Technology), in collaboration with local optometrists and the Institute of Eye Surgery at UPMC Whitfield Hospital.

Floaters are spots in your vision like black or grey specks, strings, or cobwebs that drift about when you move your eyes. According to the National Eye Institute, “almost everyone develops floaters as they get older”, but floaters can also occur from a very young age and especially in short-sighted people. Most eye floaters are caused by age-related changes in the vitreous (the jelly part of the eye). Floaters are painless and mostly harmless, but they regularly cause significant visual discomfort and, at times, mental stress for the sufferers. In some cases, floaters may be associated with retinal tears, a potential sight-threatening complication that requires immediate medical attention.

Illustration showing how eye floaters emerge: on the left, a clear view of a stone sculpture against a blue sky; in the center, a diagram of an eye cross-section depicting the vitreous humor with clumped collagen fibers floating inside; on the right, the same sculpture viewed with multiple translucent floaters obscuring the scene.

6-month dietary intervention

The FLIES trial is the first double-blind, placebo-controlled clinical trial in patients with primary floaters that demonstrated reduction in floater suffering as well as improvements in visual function in the active group compared to placebo, following a 6-month dietary intervention with a formulation consisting of 125mg l-lysine, 40mg vitamin C, 26.3mg Vitis vinifera extract, 5mg zinc, and 100mg Citrus aurantium.

Blister pack containing fifteen blue and teal capsules of Vitrocap N, arranged in three rows on a white background.

 

77% of patients demonstrated reduction in floaters

Dr. Emmanuel Ankamah, the main researcher on the FLIES trial, says “I am delighted to see the outcomes of this exciting trial published in TVST, a high impact journal in vision science. Indeed, this trial provides the evidence to support the use of targeted nutritional intervention as a management strategy for vitreous floaters. This gives us more confidence that using antioxidative and antiglycation micronutrients can improve vitreous health.”

According to Professor John Nolan, the Director of the NRCI and Principal Investigator of the FLIES trial, “This study is very interesting, as it is the first of its kind to examine the benefits of nutritional supplementation for patients suffering with vitreous floaters. Notably, a large percentage of patients (77%) on the active supplement demonstrated a reduction in vitreous floaters and associated improvements in vision-related quality of life was seen in 67% of patients.”

⇓ DOWNLOAD PUBLICATION (Ankamah E et al (2021) Translational Vision Science and Technology, 10(12):19)

2024 update

Warren Roche, PhD, lead statistician of the FLIES study, will leverage his statistical expertise to delve deeper into the original findings and explore their clinical implications within this new study. More information to be found here: https://www.opticianonline.net/content/news/vivaquity-and-ebiga-vision-launch-new-floater-study

Scientific Details

Title of publication: Dietary Intervention With a Targeted Micronutrient Formulation Reduces the Visual Discomfort Associated With Vitreous Degeneration

Research Team: Emmanuel Ankamah, Marina Green-Gomez, Warren Roche, Eugene Ng, Ulrich Welge-Lüßen, Thomas Kaercher, and John M. Nolan

Trial Overview: The FLIES study is the first to assess the impact of targeted nutritional supplementation on vitreous floaters, in the context of a randomized, double-blind, placebo-controlled clinical trial. The clinical trial included 61 patients, aged 18-79 years, who were supplemented with VitroCap®N. The evaluation was conducted using the following measures:

  1. Floater Disturbance Questionnaire: The research team utilized the Floater Disturbance Questionnaire, a short, disease-specific patient-reported outcome measure specifically designed to capture the subjective response of patients suffering from vitreous floaters as part of this study. The questionnaire comprised questions, which used response ratings, to assess the visual discomforts associated with floaters.
  2. Vitreous Opacity Area Quantification: Using the ultra-widefield imaging module of the SPECTRALIS HRA + OCT by Heidelberg Engineering GmbH, the research team captured a 30-second, 102° field, cross-polarized infrared reflectance movie of the vitreous. Patients were instructed to move their gaze in various directions, after each direction returning their gaze back to an internal fixation target. Five still images of eye floaters were extracted from the video, each captured from a different angle. Subsequently, vitreous opacity outlines were delineated manually using a ‘freehand selection’ tool. The areas of vitreous opacity from the five images were calculated individually and then combined, with the total reported in square centimeters.
  3. Visual Function Assessment: The research team evaluated visual function through various tests:
    • Best Corrected Visual Acuity (BCVA) was measured using the computerized Test Chart 2000 Xpert, employing the LogMAR Early Treatment Diabetic Retinopathy Study test chart.
    • Letter contrast sensitivity was assessed at five different spatial frequencies using the Test Chart 2000 PRO, a computerized test chart.
    • Functional contrast sensitivity was evaluated using the Acuity-plus test from the Advanced Vision and Optometric Test.
    • Cone and rod sensitivities were measured utilizing the Flicker-Plus test. 

Results: The research was able to demonstrate significant improvements in both subjective visual disturbances and in objective parameters.

  1. The complaint score improved in 67% of the patients, and the subjective reduction of eye floaters was highly significant.
Line graph from the 2021 VitroCap®N study showing visual disturbance scores over 6 months measured by a floater disturbance questionnaire. Both groups start with a mean score around 3.7. The placebo group shows a slight reduction to about 3.3, while the VitroCap®N group shows a significant decrease to about 2.0. Error bars indicate variability.

2. The vitreous opacity was reduced in 77% of the patients.

Image data from the FLIES study showing vitreous opacities using ultra-widefield imaging (102° field of view) with cross-polarized infrared light, captured using the SPECTRALIS HRA + OCT system (Heidelberg Engineering). The top row displays five extracted still frames from a 30-second video of the vitreous body taken from different gaze directions, without markings. The bottom row shows the same images with manually outlined vitreous opacities in yellow. The area of each opacity was measured and documented in the table below. The goal was to objectively quantify the total opacity area from multiple angles.

3. A significant improvement in visual function was observed concerning the contrast sensitivity..

Bar chart from the FLIES study showing changes in photopic functional contrast sensitivity (log CS/FCS) with positive contrast polarity over 6 months. Comparison of placebo (green) and VitroCap® N (blue). While the placebo group shows no significant change (p = 0.883), contrast sensitivity improves significantly in the VitroCap® N group (p = 0.047).

The observed benefit in the active group confirms that dietary intake of a formulation of antioxidative and antiglycative micronutrients could mitigate the mechanisms underlying vitreous degeneration, thereby decreasing the visual discomfort associated with vitreous floaters.