Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Официальное название

Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Обзор

The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.

Вмешательства

• Устройство MAIA
  MAIA is an automatic microperimeter with fundus imaging capabilities that measures retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the retina, thanks to its confocal scanning imaging system which uses infrared and visible light.

Первичные конечные точки

• To determine the reference normative values of retinal sensitivity for MAIA [Срок оценки: 1 day]

Вторичные конечные точки (1)

• To assess the avoidance of Serious Adverse Device Effects with MAIA [Срок оценки: through study completion (expected duration: 10 months)]

Критерии участия

Критерии включения

• Age: ≥18 years old;
• Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
• Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
• Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
• Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
• Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
• No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
• Absence of pathologies that can affect visual field in both eyes;
• No use of drugs interfering with the correct execution of perimetry.

Критерии исключения

• Glaucoma or glaucoma suspect diagnosis in either eye;
• Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
• Presence or history of disc hemorrhage in either eye;
• Presence of amblyopia in either eye;
• Nystagmus or poor fixation in either eye;
• Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
• Any active infection of anterior or posterior segments in the study eye;
• Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
• Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
• Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
• Unable to tolerate ophthalmic imaging;
• Claustrophobia;
• Inability to provide informed consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• The Eye Care Institute — Fort Lauderdale

Австралия · 1 центр

• UWA Eye Health Centre of Western Australia — Perth

Швейцария · 1 центр

• Universitätsspital Basel, Augenklinik — Basel

Идентификаторы

NCT: NCT06991127 · MAIA_003_MNDB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗