Floater Intervention Study (FLIES): supplementation trial for the reduction of visual disturbances associated with vitreous floaters

Floater Intervention Study (FLIES)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15605916

Enrollment

Registered

2017-10-31

Start date

2017-10-24

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitreous floaters Eye Diseases Vitreous floaters

Interventions

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” desi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who report primary floaters to their ophthalmologist 2. 18 years and older

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026