Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

The purpose of this study is to evaluate the safety (adverse events) and performance (visual
acuity, spectacle independence) of the SBL-3 intraocular lens.

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