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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Clinical Evaluation of a Modified Light Transmission IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: modified light transmission intraocular lens
* Device: monofocal acrylic intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZV9003<br>modified light transmission intraocular lens | Device: modified light transmission intraocular lens<br>* violet visible light blocking acrylic intraocular lens<br>* Other names: ZV9003;|
| Active Comparator: ZA9003<br>monofocal acrylic intraocular lens | Device: monofocal acrylic intraocular lens<br>* conventional hydrophobic acrylic intraocular lens<br>* Other names: ZA9003;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, monofocal, intraocular lens, acrylic