At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 445 enrolled
Drug / intervention
Tecnis Multifocal Intraocular Lens +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
In Brief
A Phase 1 clinical trial evaluating Tecnis Multifocal Intraocular Lens and Monofocal Intraocular Lens for Cataract. Completed, enrolled 445 participants across 18 sites in 2 countries.
Detailed Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartNov 2012
Primary CompletionOct 2013
Study CompletionJul 2014
TodayJul 2026
First PostedOct 26, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.7 years ago
Interventions
Tecnis Multifocal Intraocular Lensdevice
Monofocal Intraocular Lensdevice