Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Presbyopia Clinical Trial

Official title:

Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487160
• Other study ID #: SBL-INI-02-13
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: August 2019

Study information

• Verified date: May 2023
• Source: Lenstec Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataracts
• Presbyopia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The Eye Center of Central PA	Allenwood	Pennsylvania
United States	Kleiman/Evangelista Eye Center	Arlington	Texas
United States	Cape Coral Eye Center	Cape Coral	Florida
United States	Eye Center South	Dothan	Alabama
United States	Eye Centers of Florida	Fort Myers	Florida
United States	Loden Vision Center	Goodlettsville	Tennessee
United States	Whitsett Vision Group	Houston	Texas
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Carolina Eyecare Physicians	Mount Pleasant	South Carolina
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Shepard Eye Center	Santa Maria	California
United States	Newsom Eye & Laser Center	Sebring	Florida
United States	Family Eye Centers	Willmar	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Lenstec Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	photopic, distance corrected, monocular near visual acuity	a measure of near vision	1 year following implantation
Primary	presence or absence of adverse events	presence or absence of adverse events	1 year following implantation
Primary	photopic, distance corrected, monocular intermediate visual acuity	a measure of intermediate vision	1 year following implantation
Primary	photopic, best corrected, monocular distance visual acuity	a measure of distance vision	1 year following implantation
Secondary	Proportion of subjects who are independent of spectacles	a measure of the independence from spectacles	1 year following implantation