Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

• ClinicalTrials.gov Identifier: NCT02487160
• Recruitment Status: Completed
• First Posted: July 1, 2015
• Last Update Posted: July 27, 2022
• Sponsor: Lenstec Incorporated
• Information provided by (Responsible Party): Lenstec Incorporated

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cataracts; Presbyopia	Device: SBL-3 multifocal intraocular lens; Device: Control monofocal intraocular lens	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 499 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SBL-3 multifocal intraocular lens
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
• Study Start Date: August 2015
• Actual Primary Completion Date: August 2019
• Actual Study Completion Date: August 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. photopic, distance corrected, monocular near visual acuity [ Time Frame: 1 year following implantation ]
   a measure of near vision
2. presence or absence of adverse events [ Time Frame: 1 year following implantation ]
   presence or absence of adverse events
3. photopic, distance corrected, monocular intermediate visual acuity [ Time Frame: 1 year following implantation ]
   a measure of intermediate vision
4. photopic, best corrected, monocular distance visual acuity [ Time Frame: 1 year following implantation ]
   a measure of distance vision

Secondary Outcome Measures :

1. Proportion of subjects who are independent of spectacles [ Time Frame: 1 year following implantation ]
   a measure of the independence from spectacles

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Eye Center South

Dothan, Alabama, United States, 36301

United States, California

Shepard Eye Center

Santa Maria, California, United States, 93454

United States, Florida

Cape Coral Eye Center

Cape Coral, Florida, United States, 33904

Eye Centers of Florida

Fort Myers, Florida, United States, 33901

Newsom Eye & Laser Center

Sebring, Florida, United States, 33870

United States, Minnesota

Family Eye Centers

Willmar, Minnesota, United States, 56201

United States, Pennsylvania

The Eye Center of Central PA

Allenwood, Pennsylvania, United States, 17810

Eye Care Specialists

Kingston, Pennsylvania, United States, 18704

United States, South Carolina

Carolina Eyecare Physicians

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Loden Vision Center

Goodlettsville, Tennessee, United States, 37072

United States, Texas

Kleiman/Evangelista Eye Center

Arlington, Texas, United States, 76018

Whitsett Vision Group

Houston, Texas, United States, 77055

United States, Utah

The Eye Institute of Utah

Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

Lenstec Incorporated

Investigators

• Study Director: Blake Harris; Lenstec Inc

More Information

• Responsible Party: Lenstec Incorporated
• ClinicalTrials.gov Identifier: NCT02487160
• Other Study ID Numbers: SBL-INI-02-13
• First Posted: July 1, 2015
• Last Update Posted: July 27, 2022
• Last Verified: July 2022

Additional relevant MeSH terms:

Cataract; Presbyopia; Lens Diseases; Eye Diseases; Refractive Errors