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

Cataract Clinical Trial

Official title:

Clinical Evaluation of a Modified Light Transmission IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747227
• Other study ID #: BBLK-102-PRSM
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2008
• Last updated: October 6, 2011
• Start date: December 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• modified light transmission intraocular lens
violet visible light blocking acrylic intraocular lens
• monofocal acrylic intraocular lens
conventional hydrophobic acrylic intraocular lens

Locations

Country	Name	City	State
United States	Y. Ralph Chu, M.D.	Bloomington	Minnesota
United States	William Christie, M.D.	Cranberry Township	Pennsylvania
United States	Steven Silverstein, M.D.	Kansas City	Missouri
United States	Jay Rudd, M.D.	Lacey	Washington
United States	Aron Rose, M.D.	New Haven	Connecticut
United States	Mark Blecher, M.D.	Philadelphia	Pennsylvania
United States	Robert L. Bahr, M.D.	Providence	Rhode Island
United States	Randall E. Cole, M.D.	Rogers	Arkansas
United States	Jon-Marc Weston, M.D.	Roseburg	Oregon
United States	Patrick Aiello, M.D.	Scottsdale	Arizona
United States	Vance Thompson, M.D.	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Distance Visual Acuity	Snellen Equivalent visual acuity of 20/40 or better	One year	No
Primary	Uncorrected Distance Visual Acuity	Snellen Equivalent of 20/40 or better at one year	One Year	No
Secondary	Contrast Sensitivity	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.	4-6 months	No
Secondary	Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".	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.	One Year	No