Capella Scientia Development Study

ConditionCataract

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAlcon Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Subjects will be recruited from clinical sites located in India, Spain, and the Philippines.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Unity DX and SMARTCataract DX (SCDX) Biometer
Device
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
Device
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
Device
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.

Treatment groups

400 Participants

are divided into 4 treatment groups

Group A: Group 13 interventions

Group B: Group 23 interventions

Group C: Group 33 interventions

Group D: Group 43 interventions

Trial outcomes

Primary outcomes

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.

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