Skip to main content
OpenTrials
Completed

NCT Number: NCT00747227

Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Patrick Aiello, M.D., Scottsdale, Arizona, United States

Loading trial locations.

About this study

The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

modified light transmission intraocular lens

Device

violet visible light blocking acrylic intraocular lens

Other names: ZV9003

monofocal acrylic intraocular lens

Device

conventional hydrophobic acrylic intraocular lens

Other names: ZA9003

Primary outcomes

  1. Best Corrected Distance Visual Acuity

    Time frame: One year

    Snellen Equivalent visual acuity of 20/40 or better

  2. Uncorrected Distance Visual Acuity

    Time frame: One Year

    Snellen Equivalent of 20/40 or better at one year

Secondary outcomes

  1. Contrast Sensitivity

    Time frame: 4-6 months

    Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.

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

    Time frame: One Year

    Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

Clinical Evaluation of a Modified Light Transmission IOL

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2008
Registry last updated
Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.