Clinical trial Recruiting at 4 sites Observational Ages 18 and up

Capella Scientia: developing Unity DX to measure eyes with cataract.

Official title: Capella Scientia (SCDX) Development Study

Run by Alcon Research · NCT06987474 · Data updated 2026-11-12

This project will test whether the Unity DX device can reliably collect eye measurements (biometry and aberrometry) in adults with cataracts.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorAlcon Research
Industry-sponsored
Locations5 sites (Salt Lake City, Utah and 4 other locations)
StatusRecruiting
StartedJuly 30, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedOctober 30, 2026
Trial IDNCT06987474 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with cataracts who can provide informed consent, attend study visits, and have sufficiently clear optical media for imaging are ideal candidates.

Probably not a fit

Patients with nystagmus or other fixation problems, unclear optical media, contraindications to pupil dilation, women of child-bearing potential, or other ocular conditions that interfere with imaging are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, noninterventional, single-arm, unmasked, multicenter effort enrolling four cohorts simultaneously to collect biometry and aberrometry data with the next-generation Unity DX device. Measurements will be taken at sites in India, Spain, and the Philippines and compared with data from other biometers (SCDX, IOLMaster 700, and Argos with Alcon Image Guidance). Eligible adults with cataracts who can tolerate pupil dilation and fixation will undergo imaging visits without any interventional treatment. The collected data are intended to characterize device performance and support development and validation.

Why it matters

Potential benefit: If successful, Unity DX could deliver more accurate eye measurements to help surgeons pick the best intraocular lens power and improve vision outcomes after cataract surgery.

How similar studies have gone: Previous validation studies of optical biometers such as the IOLMaster 700 and Argos have shown reliable biometry results, but Unity DX as a next-generation device is being tested for equivalent or improved performance.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Eye Institute of Utah
    Salt Lake City, Utah, United States
    Recruiting
  • Asian Eye Institute
    Makati City, Philippines
    Recruiting
  • Clinica Novovision - Clinica Madrid
    Madrid, Spain
    Recruiting
  • Clinica Rementeria
    Madrid, Spain
    Recruiting
  • Narayana Nethralaya
    Bangalore, India
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.