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

Abbott Medical Optics70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataract

Interventions

One-Piece Tecnis Multifocal IOLDEVICE

One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.

One-Piece Tecnis monofocal IOL, Model ZCB00DEVICE

Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4-6 Months

Secondary Outcomes

Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity

Time frame: 4-6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.