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

Trial Summary

What is the purpose of this trial?

The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA 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 microperimetric examinations with the MAIA device during one single visit.

Research Team

Maximilian Pfau, PD Dr. med.

Principal Investigator

Universitätsspital Basel, Augenklinik

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+