RECRUITING

Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-23
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: ≥18 years old;
  2. * Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
  3. * Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
  4. * Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
  5. * 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;
  6. * Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
  7. * No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
  8. * Absence of pathologies that can affect visual field in both eyes;
  9. * No use of drugs interfering with the correct execution of perimetry.
  1. * Glaucoma or glaucoma suspect diagnosis in either eye;
  2. * Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
  3. * Presence or history of disc hemorrhage in either eye;
  4. * Presence of amblyopia in either eye;
  5. * Nystagmus or poor fixation in either eye;
  6. * Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
  7. * Any active infection of anterior or posterior segments in the study eye;
  8. * Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
  9. * Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
  10. * Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
  11. * Unable to tolerate ophthalmic imaging;
  12. * Claustrophobia;
  13. * Inability to provide informed consent.

Contacts and Locations

Study Contact

Maximilian Pfau, PD Dr. med.
CONTACT
78 215 42 67
maximilian.pfau@usb.ch

Principal Investigator

Maximilian Pfau, PD Dr. med.
STUDY_CHAIR
Universitätsspital Basel, Augenklinik

Study Locations (Sites)

The Eye Care Institute
Fort Lauderdale, Florida, 33312
United States

Collaborators and Investigators

Sponsor: Centervue SpA

  • Maximilian Pfau, PD Dr. med., STUDY_CHAIR, Universitätsspital Basel, Augenklinik

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-23
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-04-23
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Eyes