Capella Scientia Development Study

Not yet recruiting

• Conditions: Cataract

• Registration Number: NCT06987474
• Lead Sponsor: Alcon Research

Brief Summary

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 Timeline

• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Study First Posted: 2025-05-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10
• Study Start: 2025-07
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States