Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2023-07-22

Brief Summary

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To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

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Detailed Description

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Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).

Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).

Subjects will be followed for 36 Months.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Enrolled subjects will not be told which IOL they have received until the end of the study

Study Groups

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Model SC9

Investigational IOL

Group Type EXPERIMENTAL

Model SC9

Intervention Type DEVICE

Experimental

Model LI61SE

FDA Approved IOL

Group Type ACTIVE_COMPARATOR

Model LI61SE

Intervention Type DEVICE

Active Comparator

Interventions

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Model SC9

Experimental

Intervention Type DEVICE

Model LI61SE

Active Comparator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
* Able to comprehend and sign a statement of informed consent
* Willing and able to complete all required postoperative visits
* Calculated Lens Power within the available range for the study IOL's
* Planned cataract removal by phacoemulsification
* Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
* Subjects with less than 1.0D of corneal astigmatism
* Clear intraocular media other than cataract in the study eye
* Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
* Pupil size greater or equal to 6.0mm after dilation

Exclusion Criteria

* Any corneal abnormality, other than regular corneal astigmatism
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
* Previous refractive surgery
* Amblyopia
* Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
* Diabetic retinopathy
* Extremely shallow anterior chamber, not due to swollen cataract
* Microphthalmos
* Previous retinal detachment
* Previous corneal surgery
* Recurrent severe anterior or posterior segment inflammation of unknown etiology
* Rubella or traumatic cataract
* Iris Neovascularization
* Glaucoma (uncontrolled or controlled with medication)
* Aniridia
* Optic nerve atrophy
* Damaged incomplete zonules
* Systemic disease that could increase the operative risk or confound the outcome
* Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes