A Clinical Trial to Evaluate the Safety and Effectiveness of Model SC9 Silicone IOL for the Visual Correction of Aphakia Secondary to the Removal of a Cataractous Lens in Adult Patients With or Without Presbyopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 338
- Locations
- 26
- Primary Endpoint
- Improvement in Visual Acuity Measurements using the LogMar Scale
Study Overview
Brief Summary
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Enrolled subjects will not be told which IOL they have received until the end of the study
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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)
Outcomes
Primary Outcomes
Improvement in Visual Acuity Measurements using the LogMar Scale
Time Frame: 12 Months
Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16" and 80cm/32". Total letters read for each line will determine their visual acuity
Secondary Outcomes
- Defocus testing in 0.5D increments from -0.5 to -5.00D(12 Months)