Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Cataracts
• Intervention / Treatment: Device: SBL-3 multifocal intraocular lens; Device: Control monofocal intraocular lens

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: Interventional
• Enrollment (Actual): 499
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who are independent of spectacles	a measure of the independence from spectacles	1 year following implantation

Collaborators and Investigators

• Sponsor: Lenstec Incorporated
• Investigators: Study Director: Blake Harris, Lenstec Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: SBL-INI-02-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO