Recruiting

Observational Study

Sponsor:

Alcon Research

Code:

NCT06987474

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Unity DX and SMARTCataract DX (SCDX) Biometer

IOLMaster 700 Biometer

Argos with Alcon Image Guidance Biometer

Study Details

Brief summary:

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

Conditions

Cataract

Study ID

NCT06987474

Start date

Jul 30, 2025

Status verified date

Oct, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Unity 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.

IOLMaster 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.

Argos 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.

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 and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

The Eye Institute of Utah

Recruiting

Salt Lake City, Utah, United States, 84107

More Information

Sponsor

Alcon Research

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Alcon Research on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.