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The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main arm | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAIA | Device | MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values. | Agreement will be quantified by using the method proposed by Bland and Altman [1,2,3], estimating the 95%-Limits of Agreement (LoA) of the difference of threshold sensitivity values. The acceptance criteria for agreement between MAIA and MAIA 2013 EDITION is that MAIA's 95% LoA limits are within MAIA 2013 EDITION repeatability limits.
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA | The acceptance criteria is that the 95% LoA limits for MAIA are at least as narrow as MAIA 2013 EDITION repeatability limits. | 1 day |
| To assess the avoidance of Serious Adverse Device Effects with MAIA |
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Healthy Subjects
Inclusion Criteria:
Exclusion Criteria:
Patients with retinal pathology
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximilian Pfau, PD Dr. med. | Universitätsspital Basel, Augenklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Basel, Augenklinik | Basel | CH-4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40980023 | Derived | Ansari G, Giudici NL, Cancian G, Rossouw P, Rui C, Rosso A, Gazzina S, Feltgen N, Pfau K, Pfau M. Validation and Repeatability of Differential Light Sensitivity Measurements with the Novel MAIA Microperimetry Device. Ophthalmol Sci. 2025 Jul 16;5(6):100886. doi: 10.1016/j.xops.2025.100886. eCollection 2025 Nov-Dec. |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines |
| through study completion (expected duration: 3 months) |