Идёт набор NCT05438732

Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD

Без фазы С лечением Age-Related Macular Degeneration Geographic Atrophy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: smaller incision, new generation implantable miniature telescope (SING-IMT).
Кому может быть актуально: Состояния в реестре: Age-Related Macular Degeneration, Geographic Atrophy. Базовые параметры: от 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)

Обзор

The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).

Подробное описание

Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist

Вмешательства

Устройство smaller incision, new generation implantable miniature telescope (SING-IMT)
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)

Первичные конечные точки

Primary Effectiveness Outcome [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
Primary Safety Outcome [Срок оценки: Approximately 12-months post-operatively (330-420 days)]

Вторичные конечные точки (6)

Best-corrected distance visual acuity (BCDVA) [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
Best-corrected near visual acuity (BCNVA) [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
Anterior Chamber Depth [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
IMT position [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
Adverse Events [Срок оценки: Approximately 12-months post-operatively (330-420 days)]
Posterior Capsule Opacification [Срок оценки: Approximately 12-months post-operatively (330-420 days)]

Критерии участия

Критерии включения

Be at least 65 years of age at the Pre-operative Visit;
Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:

lack of need of treatment for CNV over the past 6 months, and
lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
lack of Retinal hemorrhage on exam over a 6-month period or longer
Agree to participate in post-operative visual training

For the Implanted Eye:

Have evidence of visually significant cataract at the Pre-operative Visit;
Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment

For the Non-Implanted Eye:

Have adequate peripheral vision at the Pre-operative Visit to allow navigation

Критерии исключения

Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
Have any of the following conditions at the Pre-operative Visit:

Stargardt macular dystrophy;
Diabetic retinopathy;
Untreated retinal tears;
Retinal vascular disease;
Optic nerve disease;
History of retinal detachment;
Intraocular tumor;
Retinitis pigmentosa;
History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit;
Have known allergy to post-operative medications;
History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;
Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit

For the Implanted Eye:

Have central anterior chamber depth (ACD) <3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
Have an Endothelial Cell Density (ECD) below:

2,000 cells per millimeter, if 65-84 years old;
1,800 cells per millimeter, if 85 years old or greater (based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit)
Have a history of corneal stromal or endothelial dystrophies, including guttata;
Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit;
Have an Axial Length (AL) < 21 mm at the Pre-operative Visit;
Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit;
Ongoing Inflammatory ocular disease at the Pre-operative Visit;
Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;
Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;
Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes;

For the Non-Implanted Eye: