NCT02487160

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
499

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2015

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

June 25, 2015

Last Update Submit

May 19, 2023

Conditions

CataractsPresbyopia

Outcome Measures

Primary Outcomes (4)

  • photopic, distance corrected, monocular near visual acuity

    a measure of near vision

    1 year following implantation

  • presence or absence of adverse events

    presence or absence of adverse events

    1 year following implantation

  • photopic, distance corrected, monocular intermediate visual acuity

    a measure of intermediate vision

    1 year following implantation

  • photopic, best corrected, monocular distance visual acuity

    a measure of distance vision

    1 year following implantation

Secondary Outcomes (1)

  • Proportion of subjects who are independent of spectacles

    1 year following implantation

Study Arms (2)

SBL-3 multifocal intraocular lens

EXPERIMENTAL

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

Control monofocal intraocular lens

ACTIVE COMPARATOR

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

Interventions

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

SBL-3 multifocal intraocular lens
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

Control monofocal intraocular lens

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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
  • 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

You may not qualify if:

  • 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)
  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Eye Center South

Dothan, Alabama, 36301, United States

Location

Shepard Eye Center

Santa Maria, California, 93454, United States

Location

Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Eye Centers of Florida

Fort Myers, Florida, 33901, United States

Location

Newsom Eye & Laser Center

Sebring, Florida, 33870, United States

Location

Family Eye Centers

Willmar, Minnesota, 56201, United States

Location

The Eye Center of Central PA

Allenwood, Pennsylvania, 17810, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

Loden Vision Center

Goodlettsville, Tennessee, 37072, United States

Location

Kleiman/Evangelista Eye Center

Arlington, Texas, 76018, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • 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.

    PMID: 41385130DERIVED

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Blake Harris

    Lenstec Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: SBL-3 multifocal intraocular lens
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(13)