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CataractsPhase 3NCT02487160

Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

A Phase 3 study testing SBL-3 multifocal intraocular lens in people with Cataracts and Presbyopia, run by Lenstec Incorporated at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Cataracts, Presbyopia
What is being tested?
SBL-3 multifocal intraocular lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
13 sitesUnited States
Study dates
Aug 2015to Aug 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥ 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
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  • 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

Who cannot join

  • 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)
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  • 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
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Pseudoexfoliation syndrome
  • Iris atrophy
  • Pupil abnormalities (e.g., corectopia)
  • Aniseikonia
  • 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)
  • 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.
  • Participation in another clinical trial within 30 days of study start

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • The Eye Center of Central PA

    Allenwood, Pennsylvania, 17810

  • Kleiman/Evangelista Eye Center

    Arlington, Texas, 76018

  • Cape Coral Eye Center

    Cape Coral, Florida, 33904

  • Eye Center South

    Dothan, Alabama, 36301

  • Eye Centers of Florida

    Fort Myers, Florida, 33901

  • Loden Vision Center

    Goodlettsville, Tennessee, 37072

  • Whitsett Vision Group

    Houston, Texas, 77055

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

  • Shepard Eye Center

    Santa Maria, California, 93454

  • Newsom Eye & Laser Center

    Sebring, Florida, 33870

  • Family Eye Centers

    Willmar, Minnesota, 56201

Other trials in United States

About this study

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

Read the 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.

Being tested
SBL-3 multifocal intraocular lens, Control monofocal intraocular lens
Medical subject headings
Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBL-3 multifocal intraocular lensDevice

    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 lensDevice

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

Study groups in NCT02487160
Study groupRoleWhat they receive
SBL-3 multifocal intraocular lensExperimentalThe SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
Receives: Device: SBL-3 multifocal intraocular lens
Control monofocal intraocular lensActive comparatorThe Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
Receives: Device: Control monofocal intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. photopic, distance corrected, monocular near visual acuity

    a measure of near vision

    Measured: 1 year following implantation

  2. presence or absence of adverse events

    presence or absence of adverse events

    Measured: 1 year following implantation

  3. photopic, distance corrected, monocular intermediate visual acuity

    a measure of intermediate vision

    Measured: 1 year following implantation

  4. photopic, best corrected, monocular distance visual acuity

    a measure of distance vision

    Measured: 1 year following implantation

Secondary outcomes (1)

  1. Proportion of subjects who are independent of spectacles

    a measure of the independence from spectacles

    Measured: 1 year following implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2019
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
SBL-3 multifocal intraocular lens
Masking
Single blind
Who is masked
Participant
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487160
Sponsor's protocol ID
SBL-INI-02-13
Status last verified
May 2023
First submitted
25 Jun 2015
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Shields AL, Galipeau N, Litcher-Kelly L, Moreno-Koehler A, Chacko J. The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes. J Patient Rep Outcomes. 2025 Dec 12;9(1):142. doi: 10.1186/s41687-025-00968-0.

    PubMed 41385130

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SBL-3 multifocal intraocular lens in people with Cataracts and Presbyopia, run by Lenstec Incorporated at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

photopic, distance corrected, monocular near visual acuity (time frame: 1 year following implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02487160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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