Capella Scientia Development Study

Sponsor
Alcon Research
Study ID
NCT06987474
Status
Recruiting
Apply to this trial

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Unity DX and SMARTCataract DX (SCDX) Biometer — DEVICE
    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.
  • IOLMaster 700 Biometer — DEVICE
    The IOLMaster 700 Biometer is a CE-marked, noninvasive, noncontact instrument that captures optical biometry. Data will be collected using standard clinical assessments.
  • Argos with Alcon Image Guidance Biometer — DEVICE
    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.

Study Details

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

Key Dates

First listed
May 23, 2025
Start date
Jul 30, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Group 1
    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.
  • Arm: Group 2
    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.
  • Arm: Group 3
    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.
  • Arm: Group 4
    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.

Primary Outcome Measure

Manifest Refraction Spherical Equivalent (MRSE) [ Time Frame: Group 1 and Group 4: Day 0; Group 2 and Group 3: Screening (Day -30 to Day -1), Day 30 to 60 postoperative, Day 70 to 100 postoperative ]

Central Contacts

Related Studies