Clinical trial NCT02487160: Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Official title: Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataracts
Presbyopia
Lead sponsor: Lenstec Incorporated
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 499
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SBL-3 multifocal intraocular lens
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the SBL-3 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.

Eligibility 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

Primary outcomes:
measure: photopic, distance corrected, monocular near visual acuity
timeFrame: 1 year following implantation
measure: presence or absence of adverse events
timeFrame: 1 year following implantation
measure: photopic, distance corrected, monocular intermediate visual acuity
timeFrame: 1 year following implantation
measure: photopic, best corrected, monocular distance visual acuity
timeFrame: 1 year following implantation
Secondary outcomes:
measure: Proportion of subjects who are independent of spectacles
timeFrame: 1 year following implantation
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Santa Maria
country: United States
facility: Shepard Eye Center
state: California
city: Cape Coral
country: United States
facility: Cape Coral Eye Center
state: Florida
city: Fort Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Sebring
country: United States
facility: Newsom Eye & Laser Center
state: Florida
city: Willmar
country: United States
facility: Family Eye Centers
state: Minnesota
city: Allenwood
country: United States
facility: The Eye Center of Central PA
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians
state: South Carolina
city: Goodlettsville
country: United States
facility: Loden Vision Center
state: Tennessee
city: Arlington
country: United States
facility: Kleiman/Evangelista Eye Center
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: Lenstec Inc
name: Blake Harris
role: STUDY_DIRECTOR
References: