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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Ursula Reinstein
+442045485310
ursula@theretinacliniclondon.com


Prof Paulo Stanga
+442045485310
p.stanga@theretinacliniclondon.com


Mr Sebastian Stanga
+442045485310
sebastian@theretinacliniclondon.com


Study Location:

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Be Part of Research - Trial Details - Effect of YAG Vitreolysis Laser treatment on vision-degrading vitreous floaters in short-sighted patients or patients with a posterior vitreous detachment
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Effect of YAG Vitreolysis Laser treatment on vision-degrading vitreous floaters in short-sighted patients or patients with a posterior vitreous detachment

Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Treatment of floaters in the vitreous in patients with bothersome symptoms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Floaters are small, semi-transparent specks or shapes that appear to float across a person's field of vision. They may look like dots, threads, or cobwebs and are most noticeable when looking at a bright background, such as a blue sky or a white wall. Floaters are actually tiny clumps of gel or cells that cast a shadow on the retina (the light-sensitive layer at the back of the eye), causing them to be visible. While they are generally harmless, floaters can sometimes be bothersome or interfere with clear vision.
The purpose of this study is to evaluate the efficacy and safety profile of a specific laser treatment to split floaters which are perceived by patients as bothersome into smaller pieces

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

05 May 2023 01 Jun 2025

Interventional

Intervention Type : Procedure/Surgery
Intervention Description : Only patients with bothersome floaters will be recruited for this study. They will undergo the following testing regimen:1. Visual Function testing using the ETDRS eye charts: Visual Acuity logMAR Best-Corrected Visual Acuity (BCVA) and Low Luminance Best-Corrected Visual Acuity (LL-BCVA).2. Reading function assessment using the hand-held MNREAD chart.3. Visual Function Questionnaire using the 39-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25 + Optional Items).4. VFFQ (Vitreous Floaters Functional Questionnaire).5. High-Definition Analyser (HDA)6. Light Distortion Analyser (LDA)7. C-Quant8. Contrast Sensitivity Function test using the Freiburg Acuity Contrast Test (FrACT). 9. Ultrasonography (ABSolu 20MHz annular array).10. Electroretinography (ERG) using the RETeval® Hand-Held, Full-Field ERG.11. Optos Multiwavelength and Autofluorescence Ultra widefield Imaging: Central with Steering.12. Widefield spectral domain optical coherence tomography scan (WF SD-OCT) centered on the fovea. 13. Slit lamp Biomicroscopy.14. Microperimetry.15. Indirect Ophthalmoscopy with 360-degree scleral indentation.

Eyes will only be included in this study where the posterior vitreous interface is shown to be a minimum of 3 mm from the retinal surface as measured on ultrasound and/or OCT, and where the posterior vitreous is 6 mm from the lens (1.5 lens thickness) anterior to which no floaters will be treated. Before the procedure, the pupil is dilated with 1% Tropicamide and 2.5% Phenylephrine and the surface of the eye is anesthetised using 0.4% Oxybuprocaine Hydrochloride. Then, the contact lens is placed on the eye. Under direct observation with a slit lamp biomicroscope using coaxial illumination, the laser is brought to focus upon the opacities in the vitreous body. Opacities to be treated are selected with a minimum distance of 3 mm from the retina and 6 mm from the lens to safeguard against untoward effects upon the lens anteriorly and the retina and optic disc posteriorly. The surgeon will employ a pulse offset of 300 microns to further amplify this safety zone: anteriorly offset for floaters located anterior to the mid vitreous and posterior offset for floaters located posterior to the mid vitreous. There will be no offset used for floaters in the mid vitreous.Nanosecond pulses of laser with minimum levels of energy will be applied and increased as needed to achieve photo disruption of vitreous opacities. Energy used will range between 1.5 and 5.0 mJ per single pulse with a recommended maximum total energy dose of 1,600 mJ applied in a session. Energy of 5.0 mJ is only to be used when treating floaters in the mid vitreous and lower settings should be used closer to the retina or the lens.



Anyone aged 18 years and above who is complaining of bothersome floaters in either one or both eyes. In the latter case, the retina specialist will determine which of the two eyes will be treated as part of this study.

You can take part if:



You may not be able to take part if:


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 pathology12. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Retina Clinic London
    24 Queen Anne Street
    London
    W1G 9AX

The possible benefits for the patients who suffer from bothersome floaters in their vitreous to improve visual function, quality of life and mental health.
Possible risks: We expect any risk to the patient's eye to be negligible. To avoid collateral damage, eyes will only be included in this study where the posterior vitreous interface is shown to be a minimum of 3mm from the retinal surface as measured by ultrasound and/or OCT, and where the posterior vitreous is 6mm from the lens (1.5 lens thickness) anterior to
which no floaters will be treated. The surgeon will employ a pulse offset of 300 microns (which delivers the actual laser shockwave either behind, or in front of the focusing target, depending on the setting) to further amplify this safety zone: anteriorly offset (i.e. in front of the focusing target) for floaters located anterior to the mid vitreous and posterior offset (i.e. behind the focusing target) for floaters located posterior to the mid vitreous. There will be no offset used for floaters in the mid vitreous. Energy used will range between 1.5 and 5.0 mJ per single pulse with a recommended maximum total energy dose of 1,600 mJ applied per session. Energy of 5.0 mJ is only to be used when treating floaters in the mid vitreous and lower settings should be used closer to the retina or the lens.

Prof Paulo Stanga
+442045485310
p.stanga@theretinacliniclondon.com


Mr Sebastian Stanga
+442045485310
sebastian@theretinacliniclondon.com


Dr Ursula Reinstein
+442045485310
ursula@theretinacliniclondon.com



The study is sponsored by The Retina Clinic London and funded by Investigator initiated and funded.



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Read full details for Trial ID: ISRCTN72173816
Last updated 11 March 2025

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