Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Lenstec

Status and phase: Completed; Phase 3

Conditions: Presbyopia; Cataracts

Treatments: Device: Control monofocal intraocular lens; Device: SBL-3 multifocal intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487160

SBL-INI-02-13

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.

Full 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.

Enrollment: 499 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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499 participants in 2 patient groups

SBL-3 multifocal intraocular lens

Experimental group

Description:

The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group

Treatment:

Device: SBL-3 multifocal intraocular lens

Control monofocal intraocular lens

Active Comparator group

Description:

The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group

Treatment:

Device: Control monofocal intraocular lens