Treatment of floaters in the vitreous in patients with bothersome symptoms Eye Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able and willing to give informed consent. 2. Age =18 years 3. Suffering from symptomatic vitreous floaters visible on contact lens biomicroscopy in one or both eyes. 4. Floaters arising from either/both: 4.1. Myopic vitreopathy 4.2. Posterior vitreous detachment
Exclusion criteria
Exclusion criteria: 1. Present with vitreous opacities outside of the described safety area described in section 3.1.1 (i.e., 3 mm vicinity of the retina and 6 mm vicinity of the lens). 2. Visually significant cataract that either causes sufficient media opacity to reduce quality of imaging or would require surgery during the study follow up period. 3. High risk of peripheral lesions requiring treatment at the discretion of the local PI during the study period (if patients require and receive treatment for these at screening, they may be rescreened after 2 months following procedure, at the discretion of the PI). 4. Vitreous floaters or PVD symptoms present for less than three months. 5. Unable to attend study appointments. 6. Synchysis scintillans. 7. Asteroid hyalosis. 8. Vitreous haemorrhage. 9. Active photopsia. 10. Active uveitis. 11. Active proliferative diabetic retinopathy, and/or other significant retinal vascular pathology 12. Pre-existing visual field loss (including uncontrolled glaucoma). 13. Inherited retinal diseases. 14. History of, or active ocular trauma/penetrating ocular injury. 15. Any significant vitreoretinopathy e.g., current or previous retinal detachment, epiretinal membrane, macular hole. 16. History of previous YAG laser vitreolysis treatments, or previous vitreoretinal surgery for any condition (such as retinal detachment, proliferative diabetic retinopathy). 17. History of complicated cataract surgery (e.g anterior vitrectomy). 18. History of intraocular surgery within 6 months from starting the study. 19. Any other significant ocular or non-ocular condition that, at the discretion of the local PI, puts the subject at risk or influences the results of the study. 20. Patients who, in the opinion of the investigator, would be unwilling or unable to provide written informed consent, or undergo the testing procedures as described in the protocol. 21. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Floater location, density, and acoustic scatter measured using quantitative ultrasound imaging, before and after YAG laser vitreolysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months, 6 months, 12 months: 1. Visual Acuity (ETDRS LogMAR) 2. Near Visual Acuity 3. Visual Function Questionnaire (VFQ-25) 4. Vitreous Floater Functional Questionnaire (VFFQ) 5. Contrast Sensitivity Function (CSF) 6. Quantitative Ultrasonography (B-Scan) 7. Electroretinography (ERG) 8. Optos Multiwavelength and Autofluorescence Ultrawidefield Imaging 9. Optical Coherence Tomography (OCT) 10. Microperimetry (MP) 11. Indirect Ophthalmoscopy with 360 Degree Scleral Indentation 12. High Definition Analyser (HDA) 13. Light Distortion Analyser (LDA) 14. C-Quant | — |
Countries
England, United Kingdom