YAG Laser Vitreolysis for Vitreous Floaters

Официальное название

Therapeutic Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis for Vitreous Floaters - A Study to Quantify Visual Quality of Life, Vitreous Structure, and Vision Before and After Nd:YAG Laser Vitreolysis in Patients With Vision Degrading Myodesopsia

Обзор

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.

Вмешательства

• Устройство Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
  Nd: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).

Первичные конечные точки

• Measures of vitreous structure by quantitative ultrasonography [Срок оценки: baseline, 3 months, 6 months, 12 months]

Вторичные конечные точки (8)

• Measures of visual function using contrast sensitivity [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of quality of life using Visual Function Questionnaire (VFQ-25) [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ) [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of Visual Acuity (ETDRS LogMAR) [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of Near Visual Acuity [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of retinal electrical activity changes in response to light stimuli (Photopic Negative Response amplitude) using Electroretinography (ERG) [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Visual evaluation of retinal structure changes in sagittal mode using optical coherence tomography (OCT) centered on the fovea [Срок оценки: baseline, 3 months, 6 months, 12 months]
• Evaluation of central visual field changes (median light sensitivity) using microperimetry [Срок оценки: baseline, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• 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
• Floaters arising from either/both:

• myopic vitreopathy
• posterior vitreous detachment
• Floaters meeting the following characteristics:

• Present for ≥3 months
• One single or more dense and well-defined vitreous opacities,
• A Weiss Ring or opacities which are within the safety area, at least 3mm away from the retina and 6mm away from the lens
• Visible on contact lens biomicroscopy

Критерии исключения

• 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
• Have synchysis scintillans (unusual vitreous opacities from old blood)
• Have asteroid hyalosis (unusual vitreous opacities from cholesterol)
• Have vitreous hemorrhage (fresh blood in the center of the eye)
• Have active photopsia (flashing lights)
• History of previous YAG laser vitreolysis treatments, or vitrectomy for any condition (retinal detachment, proliferative diabetic retinopathy, etc.)
• Have Posterior Vitreous Detachment (separation of vitreous away from the retina lining the inside of the back of the eye) within the past 3 months
• Are unable to attend study appointments
• Have any other significant ocular or non-ocular condition that, at the discretion of the study investigator, puts the subject at risk or influences the results of the study
• History of intraocular surgery within 6 months from study entry
• History of retinal laser within 2 months from study entry

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VMR Institute for Vitreous Macula Retina — Huntington Beach

Идентификаторы

NCT: NCT06915922 · 2023000367

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗