Floater Intervention Study (FLIES): supplementation trial for the reduction of visual disturbances associated with vitreous floaters
| ISRCTN | ISRCTN15605916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15605916 |
| Secondary identifying numbers | FLIES Version 1 |
- Submission date
- 25/10/2017
- Registration date
- 31/10/2017
- Last edited
- 07/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Floaters are moving shapes that people see floating in their vision. They can look like dots, shadows, clouds or strands. Floaters are usually harmless and don’t impact vision. However, when they move into our line of vision, they can interfere with many everyday tasks such as reading or driving. As floaters results from changes to the vitreous (a clear, jelly-like fluid in the eye), an intervention with food supplementation comprising of water-soluble antioxidants (molecules that stop oxidation), modulators of the glycation of collagens, and inhibitors of connective tissue degrading enzymes are an option to treat them. The food supplement "VitroCap NEM" could be used to help treat floaters. The aim of this study is to investigate if the food supplement VitroCap NEM can reduce visual disturbances in the vitreous.
Who can participate?
Patients aged 18 and older who have floaters in their eyes.
What does the study involve?
Participants are randomly allocated to one of two groups. One of these groups will receive the placebo capsule to taken daily by mouth for six months. The other group will receive the VitroCap NEM capsules (containing specially prepared from grape seeds and citrus fruits as well as vitamins) to take daily by mouth for six months. Participants are followed up at six months to assess the change in vitreous floater disturbances.
What are the possible benefits and risks of participating?
Participants may benefit from the treatment. There are no direct risks to volunteers participating in this research. We will inform the participant’s doctor that they will be participating in our research study.
Where is the study run from?
NOW-Science Consultancy Limited (Ireland)
When is the study starting and how long is it expected to run for?
January 2017 to December 2018
Who is funding the study?
ebiga-VISION GmbH (Germany)
Who is the main contact?
Professor John Nolan
Contact information
Scientific
Carriganore House
Waterford Institute of Technology
West Campus, Carriganore
Waterford
X91 K236
Ireland
Study information
| Study design | Single-centre double-blind placebo-controlled randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Floater Intervention Study (FLIES) |
| Study 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(s) | Research Ethics Committee, HSE, South East, Ireland, 24/04/2017 |
| 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 |
| 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 study start date | 02/01/2017 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Patients who report primary floaters to their ophthalmologist 2. 18 years and older |
| Participant exclusion criteria | 1. No secondary floaters (e.g. haemorrhage) 2. Any doctor diagnosis of retinal pathology (e.g. glaucoma, age-related macular degeneration, macular oedema, retinal detachment or scars) 3. Laser eye surgery or vitrectomy performed or scheduled in the duration of the study 4. Pregnancy 5. Alcohol or drug abuse 6. Legal incompetence or restricted legal capacity 7. Cataract surgery scheduled within the duration of this trial 8. Refractive error greater than -3D 9. Axial length longer than 25mm |
| Recruitment start date | 24/10/2017 |
| Recruitment end date | 28/02/2018 |
Locations
Countries of recruitment
- Ireland
Study participating centre
X91 K236
Ireland
Sponsor information
Industry
C/O Carriganore House
WIT West Campus
Waterford
X91 K236
Ireland
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in a high-impact peer reviewed journal expected to be published. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
07/02/2018: The following changes are made:
1. Recruitment end date was changed from 31/01/2018 to 28/02/2018.
2. Overall trial end date was changed from 31/01/2019 to 31/12/2018.
3. Intention to publish date was changed from 31/01/2020 to 31/12/2019.
