Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

NCT ID: NCT00747565

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2008-11-30

Brief Summary

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

Detailed Description

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tecnis Multifocal IOL group

Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.

Group Type: EXPERIMENTAL

Tecnis ZM900 Multifocal Intraocular Lens

Intervention Type: DEVICE

Investigational intraocular lens

CeeOn 911A monofocal control IOL group

Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.

Group Type: ACTIVE_COMPARATOR

CeeOn 911A monofocal IOL

Intervention Type: DEVICE

Monofocal Control IOL

Interventions

Tecnis ZM900 Multifocal Intraocular Lens

Investigational intraocular lens

Intervention Type: DEVICE

CeeOn 911A monofocal IOL

Monofocal Control IOL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Visual potential of 20/30 or better in each study eye
• Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
• Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
• Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria

• Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
• Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
• Uncontrolled systemic or ocular disease
• History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
• Presence of ocular pathology other than cataract such as:

• Amblyopia or strabismus
• Corneal abnormalities
• Pupil abnormalities
• Capsule or zonule abnormalities
• Intraocular inflammation
• Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
• Requiring an intraocular lens outside the study diopter range
• Contact lens usage prior to study procedure (time interval dependent upon contact lens type)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Packer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Drs. Fine, Hoffman and Packer

Other Identifiers

DIOL-104-TCNS & DIOL-101-TCNS

Identifier Type: -

Identifier Source: org_study_id