Phase 3 Completed N=250 Randomized Double-blind Treatment

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

Cataract

Source: ClinicalTrials.gov NCT00747227 ↗

Enrolled (actual)

250

Serious AEs

0.8%

Results posted

Nov 2011

Primary outcomePrimary: Best Corrected Distance Visual Acuity — 119; 120 participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Corrected Distance Visual Acuity	119; 120	—
PRIMARY Uncorrected Distance Visual Acuity	110; 116	—
SECONDARY Contrast Sensitivity	1.62; 1.62; 1.65; 1.63; 1.14; 1.17	—
SECONDARY Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".	112; 113	—

Eligibility Criteria

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 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

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Data sourced from ClinicalTrials.gov (NCT00747227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.