Cataracts, Presbyopia
Conditions
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.
Interventions
DEVICESBL-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
DEVICEControl 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
Sponsors
Lenstec Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
SBL-3 multifocal intraocular lens
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥ 22 years of age, of any race and either gender 2. Operable, age related cataract grade in both eyes 3. Patients who require an intraocular lens (IOL) power in the range of 15 D - 30 D only 4. Able to comprehend and sign a statement of informed consent 5. Calculated lens power within the available supply range 6. Planned cataract removal by phacoemulsification 7. Potential postoperative visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes 8. In good general and ocular health 9. Patients with preoperative astigmatism ≤1.0 D Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study. 10. Clear intraocular media other than cataract in study eyes 11. Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR 12. The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery 13. Able to competently complete testing 14. Willing and able to attend study visits
Exclusion criteria
1. Previous intraocular surgery 2. Preoperative photopic pupil size of \< 2.75 mm 3. Previous corneal refractive surgery 4. Any inflammation or edema (swelling) of the cornea 5. 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 6. 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) 7. Amblyopia 8. Clinically significant ptosis 9. Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia 10. Diabetic Retinopathy 11. Extremely shallow anterior chamber, not due to swollen cataract 12. Microphthalmia 13. Previous retinal detachment 14. Previous corneal transplant 15. Severe dry eye 16. Recurrent severe anterior or posterior segment inflammation of unknown etiology 17. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the Investigator \[tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)\] 18. Rubella or traumatic cataract 19. Iris neovascularization 20. Glaucoma (medically controlled or uncontrolled) 21. Aniridia 22. Chronic severe uveitis 23. Optic nerve atrophy 24. Corneal decompensation 25. Greater than 1.0 D of astigmatism 26. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) 27. Pseudoexfoliation syndrome 28. Iris atrophy 29. Pupil abnormalities (e.g., corectopia) 30. Aniseikonia 31. 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) 32. 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. 33. Participation in another clinical trial within 30 days of study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| photopic, distance corrected, monocular near visual acuity | 1 year following implantation | a measure of near vision |
| presence or absence of adverse events | 1 year following implantation | presence or absence of adverse events |
| photopic, distance corrected, monocular intermediate visual acuity | 1 year following implantation | a measure of intermediate vision |
| photopic, best corrected, monocular distance visual acuity | 1 year following implantation | a measure of distance vision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who are independent of spectacles | 1 year following implantation | a measure of the independence from spectacles |
Countries
United States
Outcome results
None listed