Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

NCT00747565 | Completed Results

• 1 other identifier: DIOL-104-TCNS & DIOL-101-TCNS
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

cataract, tecnis, multifocal, intraocular lens

Outcome Measures

Primary Outcomes (2)

• Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.

  Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.

  One year

• Mean Binocular Distance Corrected Near Visual Acuity in Snellen

  Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.

  One year

Study Arms (2)

Tecnis Multifocal IOL group

EXPERIMENTAL

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.

Device: Tecnis ZM900 Multifocal Intraocular Lens

CeeOn 911A monofocal control IOL group

ACTIVE COMPARATOR

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.

Device: CeeOn 911A monofocal IOL

Interventions

Tecnis ZM900 Multifocal Intraocular Lens DEVICE

Investigational intraocular lens

Tecnis Multifocal IOL group

CeeOn 911A monofocal IOL DEVICE

Monofocal Control IOL

CeeOn 911A monofocal control IOL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

Results from the original study (DIOL-101-TCNS) and the expansion study (DIOL-104-TCNS) were analyzed together. The original study enrolled both multifocal and monofocal control subjects; the expansion study enrolled additional multifocal subjects.

Results Point of Contact

• Title: Nicholas Tarantino, O.D., Head, Global Clinical Research & Development
• Organization: Abbott Medical Optics, Inc.

nicholas.tarantino@amo.abbott.com

866-427-8477

Study Officials

• Mark Packer, M.D.

  Drs. Fine, Hoffman and Packer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: September 3, 2008
• First Posted: September 5, 2008
• Study Start: November 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 4, 2025
• Results First Posted: December 2, 2010

Record last verified: 2025-01