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

Abbott

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Device: monofocal acrylic intraocular lens; Device: modified light transmission intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747227

BBLK-102-PRSM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

ZV9003

Experimental group

Description:

modified light transmission intraocular lens

Treatment:

Device: modified light transmission intraocular lens

ZA9003

Active Comparator group

Description:

monofocal acrylic intraocular lens

Treatment:

Device: monofocal acrylic intraocular lens