Clinical examination of a new medical device (MAIA) for conducting visual field tests (microperimetry) compared to the established MAIA-2013 device
Zusammenfassung der Studie
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)
Untersuchte Intervention
Visual field examination with the MAIA (validity compared to the gold standard and repeatability)
(BASEC)
Untersuchte Krankheit(en)
Healthy subjects and patients with retinal diseases
(BASEC)
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)
Ausschlusskriterien
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)
Studienstandort
Basel
(BASEC)
Sponsor
Professor Dr. med. Hendrik P.N. Scholl, MA
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Maximilian Pfau
+41 61 568 73 23
maximilian.pfau@clutteriob.chUniversitätsspital Basel, Augenklinik, Mittlere Strasse 91, CH-4031 Basel, Switzerland
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
07.09.2023
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar