At a glance
ClinicalIndex Comparison RecordN/ACompleted· 501 enrolled
Drug / intervention
enVista MX60E +1 moredevice
Likely dose
enVista MX60EF (trifocal) IOL implantation; enVista MX60E (monofocal) IOL implantationAI-extracted
Key inclusion· 7
- ✓Age ≥22 years
- ✓Best-corrected distance visual acuity (BCDVA) equal to or worse than 20/40 in each eye due to clinically significant cataract
- ✓BCDVA projected to be better than 20/32 after IOL implantation in each eye
- ✓Clear intraocular media other than the cataract in both eyes
Key exclusion· 16
- ✕Corneal pathology (scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye
- ✕Significant anterior segment pathology affecting IOL stability (pseudoexfoliation, synechiae, iris atrophy, lens subluxation, zonular weakness, hypermature or brunescent cataract, etc.)
- ✕Uncontrolled glaucoma in either eye
- ✕Previous retinal detachment or clinically significant retinal pathology involving the macula in either eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
In Brief
A clinical study evaluating enVista MX60E and enVista MX60EF for Cataract. Completed, enrolled 501 participants across 23 sites.
Detailed Summary
The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJul 2018
Primary CompletionMay 2023
TodayJul 2026
First PostedJul 27, 2018
Enrollment StartMay 31, 2018
Primary CompletionMay 4, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.9 years ago
Interventions
enVista MX60Edevice
enVista MX60E monofocal IOL
enVista MX60EFdevice
enVista MX60EF (trifocal) multifocal IOL (MIOL)