Capella Scientia Development Study

Alcon

Status: Begins enrollment this month

Conditions: Cataract

Treatments: Device: Argos with Alcon Image Guidance Biometer; Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer

Study type: Observational

Funder types: Industry

Identifiers

NCT06987474

CTK378-E006

Details and patient eligibility

About

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

Full description

In this prospective, noninterventional, single-arm, unmasked, multicenter study, 4 different subject cohorts will be enrolled simultaneously to collect biometry and aberrometry data using Unity DX. This study will be conducted in India, Spain, and the Philippines.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• Other group-specific, protocol required inclusion criteria may apply.

Exclusion criteria

• 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;
• Other group-specific, protocol required exclusion criteria may apply.

Trial design

400 participants in 4 patient groups

Group 1

Description:

Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Treatment:

Device: IOLMaster 700 Biometer

Device: Argos with Alcon Image Guidance Biometer

Device: Unity DX and SMARTCataract DX (SCDX) Biometer

Group 2

Description:

Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Treatment:

Device: IOLMaster 700 Biometer

Device: Argos with Alcon Image Guidance Biometer

Device: Unity DX and SMARTCataract DX (SCDX) Biometer

Group 3

Description:

Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Treatment:

Device: IOLMaster 700 Biometer

Device: Argos with Alcon Image Guidance Biometer

Device: Unity DX and SMARTCataract DX (SCDX) Biometer

Group 4

Description:

Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.

Treatment:

Device: IOLMaster 700 Biometer

Device: Argos with Alcon Image Guidance Biometer

Device: Unity DX and SMARTCataract DX (SCDX) Biometer