Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses

NCT01299155

Cataract

COMPLETED NA

Comparison of Outcomes With Multifocal Intraocular Lenses

NCT02678962

Cataract

RECRUITING NA

Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision

NCT02155348

Cataract

UNKNOWN NA

Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation

NCT00969371

Cataract

COMPLETED NA

Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

NCT01248572

Cataract

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataracts Presbyopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SBL-3 multifocal intraocular lens

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

SBL-3 multifocal intraocular lens

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Control monofocal intraocular lens

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes