Cataract
Conditions
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.
Interventions
DEVICEUnity 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.
DEVICEIOLMaster 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.
DEVICEArgos 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.
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India, Philippines, Spain
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORPrincipal II, Clinical Trial Operations, Vision Care
Alcon Research, LLC
Outcome results
None listed