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

Cataract Clinical Trial

Official title:

Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210807
• Other study ID #: DIOL-105-TMF1
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2010
• Last updated: October 29, 2015
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2015
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• One-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
• One-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.

Locations

Country	Name	City	State
Germany	Augenarzte Gemeinschaftspraxis Ahaus	Ahaus
Germany	University Eye Clinic	Heidelberg
Germany	Klinikum Ernst von Bergmann gGmbH	Potsdam
Germany	University Eye Clinic	Tubingen

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity		4-6 months	Yes