Scientific title

Floater Intervention Study (FLIES)

Acronym

FLIES

Study hypothesis

The aim of the study is to investigate if supplementation with VitroCap NEM reduces visual disturbances associated with the degeneration of the vitreous body of the eye (i.e. eye floaters disturbances).

Ethics approval

Research Ethics Committee, HSE, South East, Ireland, 24/04/2017

Study design

Single-centre double-blind placebo-controlled randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vitreous floaters

Intervention

60 participants are randomised in a 50:50 masked fashion to either active ingredient (VitroCap NEM) or placebo. Block randomisation is performed using a trial management system “Trial Controller” designed by our research group.



Active group: Participants are given VitroCap NEM capsules (containing specially prepared plant ingredients from grape seeds and citrus fruits as well as vitamin C, the amino acid L-lysine, and zinc) to take daily for a total period of 6 months.

VitroCap NEM exact contents are as follows:

1. 125 mg of L-lysine

2. 40 mg of vitamin C

3. 25 mg of Vitis vinifera extract (procyanidines)

4. 5 mg of zinc

5. 60 mg of Citrus aurantinium flavonoids



Placebo group: Participants are given placebo capsules to take daily for a total period of 6 months.



Participants in both groups are asked to attend study visits at baseline and 6-months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Change in floater disturbance is measured using a subjective questionnaire following 6 months of intervention. This will be achieved by comparing the difference in change of floater-related disturbance in participants on the active intervention versus participants on the placebo intervention.

Secondary outcome measures

1. Visual function is measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logarithm of the minimum angle of resolution (LogMAR) chart (Test Chart 2000 PRO™) for Best-corrected visual acuity (BCVA); the LogMAR EDTRS (Test Chart 2000 PRO™) for Letter Contrast Sensitivity (CS); the “Advanced Vision and Optometric Tests” (AVOT) for visual acuity, contrast sensitivity, cone and rod vision; MultiQuity (MiQ) test Suite for visual acuity and contrast sensitivity at baseline and 6-months

2. Macular pigment is measured using dual-wavelength autoflourescence, a video of floaters are captured using Scanning Laser Ophthalmoscopy (SLO) and retinal layers are measured using Optical Coherence Tomography (OCT). All outcomes listed use the Spectralis HRA + OCT Multicolour, Heidelberg at baseline and 6-months

3. Colour fundus photographs are captured using a Zeiss Visucam at baseline and 6-months

4. Reaction time is measured using the Cognition tests the Cambridge Neuropsychological Test Automated Battery (CANTAB) at baseline and 6-months

5. Blood samples are taken to measure sodium, potassium, chloride, urea, creatinine, bilirubin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma-glutamyl transferase, total protein, albumin, globulin, calcium, magnesium, phosphate, uric acid, vitamin C, glucose, highly sensitive C-reactive protein, and full blood count concentrations at baseline and 6-months

Overall trial start date

02/01/2017

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)