Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: One-Piece Tecnis Multifocal IOL; Device: One-Piece Tecnis monofocal IOL, Model ZCB00

• Registration Number: NCT01210807
• Lead Sponsor: Abbott Medical Optics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2013-05-15
• Results First Submitted QC: 2013-11-20
• Results First Posted: 2013-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• bilateral cataracts and otherwise healthy eyes
• visual potential of Decimal 0.8 in each eye

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifocal Intraocular Lens	One-Piece Tecnis Multifocal IOL	ZMB00 multifocal intraocular lens
Monofocal Intraocular Lens	One-Piece Tecnis monofocal IOL, Model ZCB00	ZCB00 monofocal intraocular lens

Primary Outcome Measures

Name	Time	Method
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm	4-6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity	4-6 months

Trial Locations

Locations (3)

Klinikum Ernst von Bergmann gGmbH; 🇩🇪 Potsdam, Germany

Augenarzte Gemeinschaftspraxis Ahaus; 🇩🇪 Ahaus, Germany

University Eye Clinic; 🇩🇪 Tubingen, Germany