MAIA Microperimeter for Healthy Eyes

Recruiting at 2 trial locations

Overseen By Maximilian Pfau, PD Dr. med.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centervue SpA

Must not be taking: Visual field drugs

Disqualifiers: Glaucoma, Ocular hypertension, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a new eye device called the MAIA, used for eye examinations. The goal is to gather information from individuals with healthy eyes to help create a database and ensure the device's safety and effectiveness. Participants will undergo a single eye exam with the MAIA device. Ideal candidates for this trial are individuals with healthy eyes who have not had recent eye surgeries or conditions like glaucoma.

As an unphased trial, this study allows participants to contribute to the development of innovative eye examination technology.

Will I have to stop taking my current medications?

The trial requires that you do not use any drugs that interfere with the correct execution of the eye test or that could cause visual field loss. If you're taking such medications, you may need to stop them to participate.

What prior data suggests that the MAIA device is safe for healthy eyes?

Research has shown that the MAIA device is generally safe. Earlier studies found no major changes in users' ability to focus their eyes or the duration of focus when using the device, indicating it does not cause noticeable problems during eye tests.

Another study is currently gathering information from healthy individuals to check for possible side effects. Researchers are actively monitoring for any issues, but no major problems have been identified so far.

As this study is in an early phase, it focuses on collecting data to ensure the device's safety before widespread availability. While no harmful side effects have been evidenced yet, ongoing research aims to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MAIA microperimeter is unique because it offers a new way to assess retinal sensitivity in healthy eyes, potentially providing more precise data than existing methods. Unlike traditional visual field tests, the MAIA uses microperimetry, which combines eye tracking with detailed mapping of retinal function. This could lead to earlier detection of eye conditions and more personalized treatment plans. Researchers are excited about this technology because it might improve our understanding of retinal health and enhance early intervention strategies.

What evidence suggests that the MAIA device is effective for healthy eyes?

Research has shown that the MAIA microperimeter effectively measures the macula's ability to detect light, which is crucial for assessing eye health. Studies confirm that it provides accurate and reliable results, comparable to the earlier version of the device. The MAIA aids doctors in understanding normal eye function across different ages, facilitating the identification of eye problems. It is important to note that the MAIA serves as a tool for measuring eye health, not for treating eye conditions. ^{2 4 5 6 7}

Who Is on the Research Team?

Maximilian Pfau, PD Dr. med.

Principal Investigator

Universitätsspital Basel, Augenklinik

Are You a Good Fit for This Trial?

This trial is for individuals with healthy eyes who are willing to participate in a single-visit study to help create a normative database for the MAIA microperimeter device, which measures visual function.

Inclusion Criteria

I do not have any eye conditions that affect my vision in both eyes.

I am not taking any medications that could affect my vision tests.

Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer)

Exclusion Criteria

I have unsteady eye movements or trouble focusing.

I have diabetic eye disease.

I have had or currently have bleeding in the disc of my eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Participants undergo one microperimetric examination with the MAIA device to collect mesopic normative data

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and adverse events after the examination

10 months

What Are the Treatments Tested in This Trial?

Interventions

• MAIA

Trial Overview The study is testing the new version of the MAIA device by collecting data from participants' eyes under low-light conditions (mesopic) to ensure its accuracy and establish safety benchmarks.

How Is the Trial Designed?

Group I: Main Arm Experimental Treatment 1 Intervention

\*) one microperimetric examination with MAIA

Who Is Running the Clinical Trial?

Centervue SpA

Lead Sponsor

Trials

2

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7414638/

Interpreting MAIA Microperimetry Using Age- and Retinal Loci ... Current interpretation of MAIA is based on an assumed uniform 25 decibel (dB) cutoff for normal function irrespective of subject age and retinal location.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525001484

Exploiting Microperimetry as a Functional End Point in ... No significant differences in fixation stability and duration between groups were observed with the MAIA device. The range between the highest and lowest PWS ...

3. nature.com nature.com/articles/s41598-021-83716-w

Improved sensitivity of microperimetric outcomes for clinical ... Among the 25 eyes there were 11.8 ± 9 and 8.4 ± 8.2 abnormal points at < 5% and < 2.5%, with mean deviation of thresholds from normal − 4.9 ± ...

4. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2802148

Multicenter Normative Data for Mesopic Microperimetry - IOVS The purpose of this study was to provide a large, multi-center normative dataset for the Macular Integrity Assessment (MAIA) microperimeter.

5. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00184-8/fulltext

Validation and Repeatability of Differential Light Sensitivity ... The MAIA3 microperimetry enables valid and reliable measurements of macular light sensitivity compared with the established device (MAIA2). Financial Disclosure ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06991127

Clinical Investigation of MAIA Microperimeter 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 ...

7. withpower.com withpower.com/trial/maia-microperimeter-for-healthy-eyes-08d37

MAIA Microperimeter for Healthy Eyes This N/A medical study run by Centervue SpA is evaluating whether MAIA will have tolerable side effects & efficacy for patients with Healthy Eyes.