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Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

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ClinicalTrials.gov Identifier: NCT02487160
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated

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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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




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

Secondary Outcome Measures :
  1. Proportion of subjects who are independent of spectacles [ Time Frame: 1 year following implantation ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487160


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

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT02487160     History of Changes
Other Study ID Numbers: SBL-INI-02-13
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors