Capella Scientia Development Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unity DX and SMARTCataract DX (SCDX) Biometer, IOLMaster 700 Biometer, Argos with Alcon Image Guidance Biometer.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India, Philippines, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Capella Scientia (SCDX) Development Study
Overview
This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.
Detailed description
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.
Interventions
- Device 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. - Device 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. - Device 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 measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Clinica Novovision - Clinica Madrid — Madrid
- Clinica Rementeria — Madrid
India · 1 center
- Narayana Nethralaya — Bangalore
Philippines · 1 center
- Asian Eye Institute — Makati City
Identifiers
NCT: NCT06987474 · CTK378-E006