Creating a database for the MAIA Microperimeter Device using healthy eyes

Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

This study is testing the MAIA Microperimeter Device by collecting information from people with healthy eyes to create a standard database that shows how the device works in low-light conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centervue SpA (Industry-sponsored)
• Locations: 3 sites (Fort Lauderdale, Florida and 2 other locations)
• Trial ID: NCT06991127 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to establish a normative database for the MAIA Microperimeter Device by collecting data from healthy subjects. Participants will undergo microperimetric examinations in a single visit to evaluate the device's safety and any adverse events. The study is multicentric and focuses on individuals with clinically normal eyes to ensure accurate baseline measurements. The data collected will help in understanding the device's performance in mesopic conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 and older with specific visual acuity and refractive criteria.

Not a fit: Patients with ocular pathologies, previous eye surgeries (except uncomplicated cataract surgery), or those with significant refractive errors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of visual field assessments in mesopic conditions, leading to improved diagnostic capabilities.

How similar studies have performed: While this approach is focused on creating a normative database, similar studies using microperimetry have shown promise in enhancing visual field assessments.

Eligibility criteria

Inclusion Criteria:

* Age: ≥18 years old;
* Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
* Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
* Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
* Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
* Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
* No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
* Absence of pathologies that can affect visual field in both eyes;
* No use of drugs interfering with the correct execution of perimetry.

Exclusion Criteria:

* Glaucoma or glaucoma suspect diagnosis in either eye;
* Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
* Presence or history of disc hemorrhage in either eye;
* Presence of amblyopia in either eye;
* Nystagmus or poor fixation in either eye;
* Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
* Any active infection of anterior or posterior segments in the study eye;
* Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
* Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
* Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
* Unable to tolerate ophthalmic imaging;
* Claustrophobia;
* Inability to provide informed consent.

Where this trial is running

Fort Lauderdale, Florida and 2 other locations

• The Eye Care Institute — Fort Lauderdale, Florida, United States (Not_yet_recruiting)
• UWA Eye Health Centre of Western Australia — Perth, Western Australia, Australia (Not_yet_recruiting)
• Universitätsspital Basel, Augenklinik — Basel, Switzerland, Switzerland (Recruiting)

Study contacts

• Study coordinator: Maximilian Pfau, PD Dr. med.

Conditions Healthy Eyes