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Clinical Trials in Spain / NCT06987474
Recruiting Observational

Capella Scientia Development Study

NCT06987474 · tracked via the Priya Life Science Spain tracker
Sponsor
Alcon Research
Phase
Observational
Started
2025-07-30
Last updated
2026-05-26

Condition(s) studied

Cataract

Investigational drug(s) / intervention(s)

Unity DX and SMARTCataract DX (SCDX) BiometerIOLMaster 700 BiometerArgos with Alcon Image Guidance Biometer

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Manifest Refraction Spherical Equivalent (MRSE) — 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.

Trial sites (4)

FacilityCityRegionStatus
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

Other trials for the same condition

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Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus Recruiting
Toric Performance And Constant Evaluation Recruiting
A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery Recruiting
Visual Performance of Clareon Vivity and PureSee IOL Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06987474 on ClinicalTrials.gov ↗ ← All trials in Spain