Capella Scientia: developing Unity DX to measure eyes with cataract.
Capella Scientia (SCDX) Development Study
This project will test whether the Unity DX device can reliably collect eye measurements (biometry and aberrometry) in adults with cataracts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 4 sites (Bangalore and 3 other locations) |
| Trial ID | NCT06987474 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with cataracts who can provide informed consent, attend study visits, and have sufficiently clear optical media for imaging are ideal candidates.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bangalore and 3 other locations
- Narayana Nethralaya — Bangalore, India (Not_yet_recruiting)
- Asian Eye Institute — Makati City, Philippines (Recruiting)
- Clinica Novovision - Clinica Madrid — Madrid, Spain (Recruiting)
- Clinica Rementeria — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.