RecruitingNCT06987474

Capella Scientia Development Study

Capella Scientia (SCDX) Development Study

Sponsor

Alcon Research

Enrollment

400 participants

Start Date

Jul 30, 2025

Study Type

OBSERVATIONAL

Conditions

Cataract

Summary

This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Able to understand and sign an IRB/IEC approved consent form;
Willing and able to attend study visit(s) as required by the protocol;
Consenting age at the jurisdiction of study site;

Exclusion Criteria5

Women of child-bearing potential;
Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
Unclear optical media preventing data capture from all devices in the study;
Contraindicated for pupil dilation (e.g., narrow angles, allergies) per investigator's clinical judgment;
Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study;

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Interventions

DEVICEUnity DX and SMARTCataract DX (SCDX) Biometer

Unity DX is a CE-marked, noninvasive, noncontact instrument that generates a 3D model of the eye using hyper parallel optical coherence tomography (HP OCT), aberrometry, and topography. The current version of SCDX software will be used in this study.

DEVICEIOLMaster 700 Biometer

The IOLMaster 700 Biometer is a CE-marked, noninvasive, noncontact instrument that captures optical biometry. Data will be collected using standard clinical assessments.

DEVICEArgos with Alcon Image Guidance Biometer

The Argos with Alcon Image Guidance biometer is a CE-marked, noninvasive, noncontact instrument that will capture optical biometry. Data will be collected using standard clinical assessments.