Status:
COMPLETED
Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology
Lead Sponsor:
Centervue SpA
Conditions:
Healthy Eyes
Retinal Diseases
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Healthy Subjects
- Age: 18-90 years old;
- BCVA ≥ 0.8 Decimal;
- Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
- IOP ≤ 21 mmHg;
- Clinically normal appearance of the optic nerve head (examined with Spectralis OCT);
- Clinically normal appearance of the macula (examined with Spectralis OCT);
- No ocular pathologies, trauma, surgeries;
- Absence of pathologies that can affect visual field;
- No use of drugs inferfering with the correct execution of perimetry;
Exclusion
- Glaucoma or glaucoma suspect diagnosis;
- IOP ≥ 22 mmHg;
- Presence or history of disc hemorrhage;
- Presence of amblyopia;
- Nystagmus or poor fixation;
- Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment;
- Any active infection of anterior or posterior segments;
- Subjects with significant ocular media opacities;
- Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease;
- Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
- Unable to tolerate ophthalmic imaging;
- Claustrophobia;
- Inability to provide informed consent.
- Patients with retinal pathology
- Inclusion Criteria:
- Age: 18-90 years old;
- BCVA ≥ 0.1 Decimal;
- Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
- Diagnosis of any type of retinal disease by investigator based on fundoscopy and Spectralis OCT for which microperimetry is indicated;
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06071546
Start Date
October 17 2023
End Date
July 12 2024
Last Update
August 13 2024
Active Locations (1)
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1
Universitätsspital Basel, Augenklinik
Basel, Switzerland, CH-4031