Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 13, 2013
CompletedFebruary 4, 2025
January 1, 2025
1.7 years
June 17, 2010
May 15, 2013
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
4-6 Months
Secondary Outcomes (1)
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
4-6 months
Study Arms (2)
Multifocal Intraocular Lens
EXPERIMENTALZMB00 multifocal intraocular lens
Monofocal Intraocular Lens
ACTIVE COMPARATORZCB00 monofocal intraocular lens
Interventions
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Eligibility Criteria
You may qualify if:
- bilateral cataracts and otherwise healthy eyes
- visual potential of Decimal 0.8 in each eye
You may not qualify if:
- any medications affecting vision
- any chronic disease/illness that would affect risk to subject or outcomes of the study
- any ocular pathology/abnormalities that may affect visual outcomes or confound study results
- desire for monovision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- PD Dr. med. Peter Szurman
- Organization
- University Eye Clinic, Tubingen, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Szurman, PD Dr. med.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
September 29, 2010
Study Start
November 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 4, 2025
Results First Posted
December 13, 2013
Record last verified: 2025-01