CataractNCT06987474
Capella Scientia Development Study
An observational study of Cataract, run by Alcon Research at 4 sites in 3 countries.
Trial summary
This study involves collecting biometry and aberration data using the next generation biometer, Unity DX. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Unity DX and SMARTCataract DX (SCDX) Biometer, IOLMaster 700 Biometer and Argos with Alcon Image Guidance Biometer
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Jul 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects will be recruited from clinical sites located in India, Spain, and the Philippines.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Clinica Novovision - Clinica Madrid
Madrid, 28046
- Recruiting
Clinica Rementeria
Madrid, 28101
India1 site, 1 recruiting
- Not yet recruiting
Narayana Nethralaya
Bangalore, 560010
Philippines1 site, 1 recruiting
- Recruiting
Asian Eye Institute
Makati City, 1200
About this study
Official title: Capella Scientia (SCDX) Development Study
This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.
Read the 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.
- Conditions
- Cataract
- Being tested
- Unity DX and SMARTCataract DX (SCDX) Biometer, IOLMaster 700 Biometer, Argos with Alcon Image Guidance Biometer
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unity DX and SMARTCataract DX (SCDX) BiometerDevice
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 BiometerDevice
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 BiometerDevice
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. Receives: Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer | |
| Group 2 | Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. Receives: Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer | |
| Group 3 | Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. Receives: Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer | |
| Group 4 | Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. Receives: Device: Unity DX and SMARTCataract DX (SCDX) Biometer; Device: IOLMaster 700 Biometer; Device: Argos with Alcon Image Guidance Biometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manifest Refraction Spherical Equivalent (MRSE)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start30 Jul 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal II, Clinical Trial Operations, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987474
- Sponsor's protocol ID
- CTK378-E006
- Status last verified
- May 2026
- First submitted
- 16 May 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capella Scientia (SCDX) Development Study
- ClinicalTrials.gov ID
- NCT06987474
- Acronym / sponsor ID
- CTK378-E006
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Unity DX and SMARTCataract DX (SCDX) Biometer, Device: IOLMaster 700 Biometer, Device: Argos with Alcon Image Guidance BiometerSubjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. |
| Group 2 | – | Device: Unity DX and SMARTCataract DX (SCDX) Biometer, Device: IOLMaster 700 Biometer, Device: Argos with Alcon Image Guidance BiometerSubjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. |
| Group 3 | – | Device: Unity DX and SMARTCataract DX (SCDX) Biometer, Device: IOLMaster 700 Biometer, Device: Argos with Alcon Image Guidance BiometerSubjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. |
| Group 4 | – | Device: Unity DX and SMARTCataract DX (SCDX) Biometer, Device: IOLMaster 700 Biometer, Device: Argos with Alcon Image Guidance BiometerSubjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from clinical sites located in India, Spain, and the Philippines.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unity DX and SMARTCataract DX (SCDX) BiometerUnity 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 | Group 1, Group 2, Group 3, Group 4 |
| IOLMaster 700 BiometerThe IOLMaster 700 Biometer is a CE-marked, noninvasive, noncontact instrument that captures optical biometry. Data will be collected using standard clinical assessments. | Device | Group 1, Group 2, Group 3, Group 4 |
| Argos with Alcon Image Guidance BiometerThe 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. | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Principal II, Clinical Trial Operations, Vision Care study director
Alcon Research, LLC
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Alcon Research at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, India, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.