Informazioni generali
  • Categoria della malattia Malattie oftalmiche (BASEC)
  • Stato di reclutamento reclutamento completato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Maximilian Pfau maximilian.pfau@iob.ch (BASEC)
  • Fonte dati BASEC: Importato da 11.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 11.07.2025 10:55
HumRes63145 | SNCTP000005621 | BASEC2023-D0049

Clinical examination of a new medical device (MAIA) for conducting visual field tests (microperimetry) compared to the established MAIA-2013 device

  • Categoria della malattia Malattie oftalmiche (BASEC)
  • Stato di reclutamento reclutamento completato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Maximilian Pfau maximilian.pfau@iob.ch (BASEC)
  • Fonte dati BASEC: Importato da 11.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 11.07.2025 10:55

Descrizione riassuntiva dello studio

The overarching purpose of this study is to characterize the new MAIA perimeter for visual field examination (microperimetry). Study objectives: 1. To ensure that the visual field measurements are accurate, it will be evaluated whether the measurement results are comparable to those of the established MAIA-2013 device (validity). 2. Additionally, the visual field examination will be repeated on both devices to assess the repeatability for the new device (retest reliability). Procedure: First, a brief ophthalmological routine examination will be conducted, including the assessment of visual acuity, determination of intraocular pressure, and imaging of the retina (SD-OCT). During the visual field examination, weak light points of varying brightness will be presented. By pressing a response button, participants can determine the perception threshold for different locations in the visual field. A total of four visual field examinations will be conducted: two with the new device, two with the established device.

(BASEC)

Intervento studiato

Visual field examination with the MAIA (validity compared to the gold standard and repeatability)

(BASEC)

Malattie studiate

Healthy subjects and patients with retinal diseases

(BASEC)

Criteri di partecipazione
Inclusion criteria for the group of healthy subjects 1. Age: 18-90 years; 2. Best corrected visual acuity (BCVA): ≥ 0.8 decimal (20/25 ft, +0.1 LogMAR) at least in the study eye; 3. Spherical equivalent between -12 dpt and +6 dpt; astigmatism less than 2 dpt at least in the study eye; 4. Intraocular pressure (IOD) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer); 5. Clinically normal appearance of the optic nerve head (no signs of increased excavation, rim thinning, notches, disc margin hemorrhages, RNFL thinning) in both eyes. This will be examined with Spectralis OCT; 6. Clinically normal appearance of the macula, in both eyes. This will be examined with Spectralis OCT; 7. No ocular pathologies, trauma, surgeries (except for an uncomplicated cataract surgery performed at least 6 months prior to study enrollment) in both eyes; 8. Absence of pathologies that may affect the visual field in both eyes; 9. No intake of medications that may affect the proper execution of perimetry. Inclusion criteria for the group of patients with retinal diseases 1. Age: 18-90 years; 2. BCVA: ≥ 0.1 decimal (20/200 ft, +1.0 logmar) at least in the study eye; 3. Spherical equivalent between -12 dpt and +6 dpt; astigmatism less than 2 dpt at least in the study eye; 4. Diagnosis of any type of retinal disease by the investigator based on funduscopy and Spectralis OCT, for which a microperimetry examination is indicated, at least in the study eye. This includes, among others: early and intermediate age-related macular degeneration (AMD), geographic atrophy (GA), neovascular AMD, history of retinal pigment epithelium (RPE)-choroid transplantation, diabetic retinopathy (DR), retinal vascular diseases, pathological myopia, retinal dystrophies, vitreoretinal interface disorders, inflammatory chorioretinal disorders, toxic retinopathies, glaucoma, and others. (BASEC)

Criteri di esclusione
Exclusion criteria for the group of healthy subjects 1. Glaucoma or glaucoma-suspect diagnosis in either eye; 2. Presence or history of ocular hypertension (IOD ≥ 22 mmHg) in either eye; 3. Presence or history of disc margin hemorrhage in either eye; 4. Amblyopia in either eye; 5. Nystagmus or poor fixation in either eye; 6. Previous laser or other eye surgeries, including uncomplicated cataract surgeries, performed within 6 months prior to study enrollment in both eyes; 7. Any active infection of the anterior or posterior segments of the study eye; 8. Subjects with significant media opacities preventing acceptable quality of fundus imaging in the 9th infrared domain (IR) of the study eye; 9. Signs of diabetic retinopathy, diabetic macular edema, or other retinal diseases in either eye; 10. Intake of medications that may affect the proper execution of MP or may lead to visual field losses; 11. Intolerance to ophthalmic imaging; 12. Claustrophobia; 13. Inability to provide informed consent. Exclusion criteria for the group of patients with retinal diseases 1. Any ophthalmic surgery on the study eye. Exception: uncomplicated cataract surgery performed at least 6 months prior to the start of the study; 2. Subjects who cannot tolerate ophthalmic imaging; 3. Nystagmus in either eye; 4. Subjects with significant media opacities preventing acceptable quality of IR fundus images in the study eye; 5. Intake of medications that may affect the proper execution of MP or may lead to visual field losses; 6. Claustrophobia; 7. Inability to provide informed consent; 8. In the investigator's assessment, at-risk subjects (i.e., recent [3 months] or imminent deterioration of vision [3 lines on an ETDRS visual acuity chart]). (BASEC)

Luogo dello studio

Basilea

(BASEC)

non disponibile

Sponsor

Professor Dr. med. Hendrik P.N. Scholl, MA

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Maximilian Pfau

+41 ‪61 568 73 23

maximilian.pfau@iob.ch

Universitätsspital Basel, Augenklinik, Mittlere Strasse 91, CH-4031 Basel, Switzerland

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

07.09.2023

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Pre-market monocentric cross-sectional clinical investigation of MAIA on healthy subjects and patients with retinal pathology: agreement with MAIA 2013 EDITION microperimeter and repeatability evaluation (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile