Clinical examination of a new medical device (MAIA) for conducting visual field tests (microperimetry) compared to the established MAIA-2013 device
Summary description of the study
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)
Intervention under investigation
Visual field examination with the MAIA (validity compared to the gold standard and repeatability)
(BASEC)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Basel
(BASEC)
Sponsor
Professor Dr. med. Hendrik P.N. Scholl, MA
(BASEC)
Contact
Contact Person Switzerland
Maximilian Pfau
+41 61 568 73 23
maximilian.pfau@clutteriob.chUniversitätsspital Basel, Augenklinik, Mittlere Strasse 91, CH-4031 Basel, Switzerland
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
07.09.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available