NCT00747227

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 11, 2011

Completed
Last Updated

November 11, 2011

Status Verified

October 1, 2011

Enrollment Period

2.2 years

First QC Date

September 3, 2008

Results QC Date

March 4, 2011

Last Update Submit

October 6, 2011

Conditions

Cataract

Keywords

cataractmonofocalintraocular lensacrylic

Outcome Measures

Primary Outcomes (2)

  • Best Corrected Distance Visual Acuity

    Snellen Equivalent visual acuity of 20/40 or better

    One year

  • Uncorrected Distance Visual Acuity

    Snellen Equivalent of 20/40 or better at one year

    One Year

Secondary Outcomes (2)

  • Contrast Sensitivity

    4-6 months

  • Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".

    One Year

Study Arms (2)

ZV9003

EXPERIMENTAL

modified light transmission intraocular lens

Device: modified light transmission intraocular lens

ZA9003

ACTIVE COMPARATOR

monofocal acrylic intraocular lens

Device: monofocal acrylic intraocular lens

Interventions

modified light transmission intraocular lensDEVICE

violet visible light blocking acrylic intraocular lens

Also known as: ZV9003
ZV9003
monofocal acrylic intraocular lensDEVICE

conventional hydrophobic acrylic intraocular lens

Also known as: ZA9003
ZA9003

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years of age or older
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
  • Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
  • Preoperative corneal astigmatism of 1.5 diopters or less

You may not qualify if:

  • Use of systemic or ocular medications that may affect vision
  • Uncontrolled systemic or recurrent ocular disease
  • Requiring an intraocular lens \<15.0 or \>26.0 diopters
  • Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
  • History of ocular trauma or prior ocular surgery
  • Known pathology that may affect visual acuity or visual field
  • Corneal abnormalities
  • Pupil abnormalities
  • Capsule or zonular abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Patrick Aiello, M.D.

Scottsdale, Arizona, 85054, United States

Location

Randall E. Cole, M.D.

Rogers, Arkansas, 72756, United States

Location

Aron Rose, M.D.

New Haven, Connecticut, 06510, United States

Location

Y. Ralph Chu, M.D.

Bloomington, Minnesota, 55420, United States

Location

Steven Silverstein, M.D.

Kansas City, Missouri, 64133, United States

Location

Jon-Marc Weston, M.D.

Roseburg, Oregon, 97470, United States

Location

William Christie, M.D.

Cranberry Township, Pennsylvania, 16066, United States

Location

Mark Blecher, M.D.

Philadelphia, Pennsylvania, 19148, United States

Location

Robert L. Bahr, M.D.

Providence, Rhode Island, 02906, United States

Location

Vance Thompson, M.D.

Sioux Falls, South Dakota, 57105, United States

Location

Jay Rudd, M.D.

Lacey, Washington, 98503, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Nicholas Taranatino, O.D., Head, Global Clinical Research & Devlopment
Organization
Abbott medical Optics, Inc.
nicholas.tarantino@amo.abbott.com
866-427-8477

Study Officials

  • Roger F. Steinert, M.D.

    University of California, Irvine, Dept. of Ophthalmology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

December 1, 2006

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

November 11, 2011

Results First Posted

November 11, 2011

Record last verified: 2011-10

Locations

US(11)