Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Phase 3
Completed
- Conditions
- PresbyopiaCataracts
- Interventions
- Device: Control monofocal intraocular lensDevice: SBL-3 multifocal intraocular lens
- Registration Number
- NCT02487160
- Lead Sponsor
- Lenstec Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.
- Detailed Description
The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 499
Inclusion Criteria
- ≥ 22 years of age, of any race and either gender
- Operable, age related cataract grade in both eyes
- Patients who require an intraocular lens (IOL) power in the range of 15 D - 30 D only
- Able to comprehend and sign a statement of informed consent
- Calculated lens power within the available supply range
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes
- In good general and ocular health
- Patients with preoperative astigmatism ≤1.0 D Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
- Clear intraocular media other than cataract in study eyes
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
- The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
- Able to competently complete testing
- Willing and able to attend study visits
Exclusion Criteria
- Previous intraocular surgery
- Preoperative photopic pupil size of < 2.75 mm
- Previous corneal refractive surgery
- Any inflammation or edema (swelling) of the cornea
- 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
- Subjects who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than neodymium-doped yttrium aluminium garnet (nd:YAG) capsulotomy)
- Amblyopia
- Clinically significant ptosis
- Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
- Diabetic Retinopathy
- Extremely shallow anterior chamber, not due to swollen cataract
- Microphthalmia
- Previous retinal detachment
- Previous corneal transplant
- Severe dry eye
- Recurrent severe anterior or posterior segment inflammation of unknown etiology
- Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the Investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)]
- Rubella or traumatic cataract
- Iris neovascularization
- Glaucoma (medically controlled or uncontrolled)
- Aniridia
- Chronic severe uveitis
- Optic nerve atrophy
- Corneal decompensation
- Greater than 1.0 D of astigmatism
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Pseudoexfoliation syndrome
- Iris atrophy
- Pupil abnormalities (e.g., corectopia)
- Aniseikonia
- An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- Pregnant, lactating, or planning to become pregnant during the course of the trial Note: Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
- Participation in another clinical trial within 30 days of study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control monofocal intraocular lens Control monofocal intraocular lens The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group SBL-3 multifocal intraocular lens SBL-3 multifocal intraocular lens The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
- Primary Outcome Measures
Name Time Method photopic, distance corrected, monocular intermediate visual acuity 1 year following implantation a measure of intermediate vision
photopic, distance corrected, monocular near visual acuity 1 year following implantation a measure of near vision
photopic, best corrected, monocular distance visual acuity 1 year following implantation a measure of distance vision
presence or absence of adverse events 1 year following implantation presence or absence of adverse events
- Secondary Outcome Measures
Name Time Method Proportion of subjects who are independent of spectacles 1 year following implantation a measure of the independence from spectacles
Trial Locations
- Locations (13)
Eye Center South
🇺🇸Dothan, Alabama, United States
Shepard Eye Center
🇺🇸Santa Maria, California, United States
Eye Centers of Florida
🇺🇸Fort Myers, Florida, United States
Cape Coral Eye Center
🇺🇸Cape Coral, Florida, United States
Newsom Eye & Laser Center
🇺🇸Sebring, Florida, United States
The Eye Center of Central PA
🇺🇸Allenwood, Pennsylvania, United States
Family Eye Centers
🇺🇸Willmar, Minnesota, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Carolina Eyecare Physicians
🇺🇸Mount Pleasant, South Carolina, United States
Loden Vision Center
🇺🇸Goodlettsville, Tennessee, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
Kleiman/Evangelista Eye Center
🇺🇸Arlington, Texas, United States
Whitsett Vision Group
🇺🇸Houston, Texas, United States