YAG Laser Vitreolysis for Vitreous Floaters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVMR Consulting, Inc.
About this trial
The purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) that fills the center of eye which cause vision disturbances commonly called "floaters".
In this study the vitreous floaters are treated using a Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The FDA has approved the use of this laser to treat membranes in the eye.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Only one eye per patient will be included in this study
Able and willing to give informed consent
Age ≥18 years
Suffering from symptomatic vitreous floaters
Disqualifiers
Patient presenting with vitreous opacities outside of the described safety area (within 3mm of the retina or 6mm from the lens)
Have clinically significant cataract (lens opacification) in one or both eyes which are in the opinion of the examining doctor more significant in impacting vision as compared to that caused by vitreous opacities; or cataract expected to need cataract surgery during the duration of the study
Present with untreated retinal tears or retinal holes requiring treatment at the discretion of the study investigator
Have high risk of peripheral lesions requiring treatment at the discretion of the study investigator
Trial design
Design model
Single group
Treatments tested in this trial
Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
DeviceNd:YAG laser treatment(s) for Vision Degrading Myodesopsia (clinically significant vitreous floaters) in eyes with vitreous opacities due to myopic vitreopathy and posterior vitreous detachment (PVD).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser VitreolysisOther 1 intervention
Trial outcomes
Primary outcomes
1
Measures of vitreous structure by quantitative ultrasonography
Time frame
baseline, 3 months, 6 months, 12 monthsSecondary outcomes
1
Measures of visual function using contrast sensitivity
Time frame
baseline, 3 months, 6 months, 12 months2
Evaluation of quality of life using Visual Function Questionnaire (VFQ-25)
Individual scores (NEI VFQ 25 score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst
Time frame
baseline, 3 months, 6 months, 12 months3
Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ)
Individual scores (VFFQ score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst
Time frame
baseline, 3 months, 6 months, 12 months4
Evaluation of Visual Acuity (ETDRS LogMAR)
Time frame
baseline, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VMR Consulting, Inc.
Lead sponsor
The Retina Clinic - London Ophthalmic Institute
Collaborator
Source ClinicalTrials.gov