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NCT Number: NCT06987474

Capella Scientia Development Study

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Narayana Nethralaya, Bangalore, India

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent is calculated by adding the sum of the sphere power with half of the cylinder power. MRSE will be reported in diopters.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Capella Scientia (SCDX) Development Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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