At a glance
ClinicalIndex Comparison RecordN/ACompleted· 376 enrolled
Drug / intervention
Clareon aspheric hydrophobic acrylic monofocal IOLdevice
Likely dose
Clareon aspheric hydrophobic acrylic monofocal IOL implantation (single device per eye)AI-extracted
Key inclusion· 3
- ✓Planned routine cataract surgery in at least one eye
- ✓Calculated lens power within the available range
- ✓Clear intraocular media other than cataract
Key exclusion· 5
- ✕Disease or pathology (other than cataract) expected to reduce postoperative best corrected distance visual acuity to worse than 0.30 logMAR
- ✕Previous corneal surgery
- ✕Rubella or traumatic cataract
- ✕Ocular trauma or previous refractive surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation of the Clareon® IOL
In Brief
A clinical study evaluating Clareon aspheric hydrophobic acrylic monofocal IOL for Cataract. Completed, enrolled 376 participants across 16 sites.
Detailed Summary
The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJul 2017
Primary CompletionFeb 2019
TodayJul 2026
First PostedMay 30, 2017
Enrollment StartJul 25, 2017
Primary CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.1 years ago
Interventions
Clareon aspheric hydrophobic acrylic monofocal IOLdevice
Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.