Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Completed · Phase 3
Conditions studied: Cataracts, Presbyopia
In brief
The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.
Key facts
- Study ID
- NCT02487160
- Run by
- Lenstec Incorporated
- People needed
- 499
- Starts
- 2015-08-01
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2023-05-23
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Eye Center South — Dothan, Alabama, United States
- Shepard Eye Center — Santa Maria, California, United States
- Cape Coral Eye Center — Cape Coral, Florida, United States
- Eye Centers of Florida — Fort Myers, Florida, United States
- Newsom Eye & Laser Center — Sebring, Florida, United States
- Family Eye Centers — Willmar, Minnesota, United States
- The Eye Center of Central PA — Allenwood, Pennsylvania, United States
- Eye Care Specialists — Kingston, Pennsylvania, United States
- Carolina Eyecare Physicians — Mt. Pleasant, South Carolina, United States
- Loden Vision Center — Goodlettsville, Tennessee, United States
- Kleiman/Evangelista Eye Center — Arlington, Texas, United States
- Whitsett Vision Group — Houston, Texas, United States
- The Eye Institute of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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