Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

May 19, 2023 updated by: Lenstec Incorporated
The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
499

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Eye Center South
    • California
      • Santa Maria, California, United States, 93454
        • Shepard Eye Center
    • Florida
      • Cape Coral, Florida, United States, 33904
        • Cape Coral Eye Center
      • Fort Myers, Florida, United States, 33901
        • Eye Centers of Florida
      • Sebring, Florida, United States, 33870
        • Newsom Eye & Laser Center
    • Minnesota
      • Willmar, Minnesota, United States, 56201
        • Family Eye Centers
    • Pennsylvania
      • Allenwood, Pennsylvania, United States, 17810
        • The Eye Center of Central PA
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Loden Vision Center
    • Texas
      • Arlington, Texas, United States, 76018
        • Kleiman/Evangelista Eye Center
      • Houston, Texas, United States, 77055
        • Whitsett Vision Group
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: 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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
photopic, distance corrected, monocular near visual acuity
Time Frame: 1 year following implantation
a measure of near vision
1 year following implantation
presence or absence of adverse events
Time Frame: 1 year following implantation
presence or absence of adverse events
1 year following implantation
photopic, distance corrected, monocular intermediate visual acuity
Time Frame: 1 year following implantation
a measure of intermediate vision
1 year following implantation
photopic, best corrected, monocular distance visual acuity
Time Frame: 1 year following implantation
a measure of distance vision
1 year following implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects who are independent of spectacles
Time Frame: 1 year following implantation
a measure of the independence from spectacles
1 year following implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lenstec Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Blake Harris, Lenstec Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBL-INI-02-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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