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Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date October 18, 2018
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • photopic, distance corrected, monocular near visual acuity [ Time Frame: 1 year following implantation ]
  • presence or absence of adverse events [ Time Frame: 1 year following implantation ]
  • photopic, distance corrected, monocular intermediate visual acuity [ Time Frame: 1 year following implantation ]
  • photopic, best corrected, monocular distance visual acuity [ Time Frame: 1 year following implantation ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02487160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
Proportion of subjects who are independent of spectacles [ Time Frame: 1 year following implantation ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Official Title  ICMJE Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataracts
  • Presbyopia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Device: SBL-3 multifocal intraocular lens
  • 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
    Intervention: Device: Control monofocal intraocular lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2015)
510
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487160
Other Study ID Numbers  ICMJE SBL-INI-02-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lenstec Incorporated
Study Sponsor  ICMJE Lenstec Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Blake Harris Lenstec Inc
PRS Account Lenstec Incorporated
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP