Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-01 @ 10:05 AM
Study NCT ID:
NCT02487160
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SBL-3 multifocal intraocular lens'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'photopic, distance corrected, monocular near visual acuity', 'timeFrame': '1 year following implantation', 'description': 'a measure of near vision'}, {'measure': 'presence or absence of adverse events', 'timeFrame': '1 year following implantation', 'description': 'presence or absence of adverse events'}, {'measure': 'photopic, distance corrected, monocular intermediate visual acuity', 'timeFrame': '1 year following implantation', 'description': 'a measure of intermediate vision'}, {'measure': 'photopic, best corrected, monocular distance visual acuity', 'timeFrame': '1 year following implantation', 'description': 'a measure of distance vision'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who are independent of spectacles', 'timeFrame': '1 year following implantation', 'description': 'a measure of the independence from spectacles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataracts', 'Presbyopia']}, 'referencesModule': {'references': [{'pmid': '41385130', 'type': 'DERIVED', 'citation': 'Shields AL, Galipeau N, Litcher-Kelly L, Moreno-Koehler A, Chacko J. The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes. J Patient Rep Outcomes. 2025 Dec 12;9(1):142. doi: 10.1186/s41687-025-00968-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.', 'detailedDescription': 'The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 22 years of age, of any race and either gender\n2. Operable, age related cataract grade in both eyes\n3. Patients who require an intraocular lens (IOL) power in the range of 15 D - 30 D only\n4. Able to comprehend and sign a statement of informed consent\n5. Calculated lens power within the available supply range\n6. Planned cataract removal by phacoemulsification\n7. Potential postoperative visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes\n8. In good general and ocular health\n9. Patients with preoperative astigmatism ≤1.0 D Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.\n10. Clear intraocular media other than cataract in study eyes\n11. Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR\n12. The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery\n13. Able to competently complete testing\n14. Willing and able to attend study visits\n\nExclusion Criteria:\n\n1. Previous intraocular surgery\n2. Preoperative photopic pupil size of \\< 2.75 mm\n3. Previous corneal refractive surgery\n4. Any inflammation or edema (swelling) of the cornea\n5. 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\n6. 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)\n7. Amblyopia\n8. Clinically significant ptosis\n9. Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia\n10. Diabetic Retinopathy\n11. Extremely shallow anterior chamber, not due to swollen cataract\n12. Microphthalmia\n13. Previous retinal detachment\n14. Previous corneal transplant\n15. Severe dry eye\n16. Recurrent severe anterior or posterior segment inflammation of unknown etiology\n17. 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)\\]\n18. Rubella or traumatic cataract\n19. Iris neovascularization\n20. Glaucoma (medically controlled or uncontrolled)\n21. Aniridia\n22. Chronic severe uveitis\n23. Optic nerve atrophy\n24. Corneal decompensation\n25. Greater than 1.0 D of astigmatism\n26. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)\n27. Pseudoexfoliation syndrome\n28. Iris atrophy\n29. Pupil abnormalities (e.g., corectopia)\n30. Aniseikonia\n31. 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)\n32. 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.\n33. Participation in another clinical trial within 30 days of study start'}, 'identificationModule': {'nctId': 'NCT02487160', 'briefTitle': 'Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lenstec Incorporated'}, 'officialTitle': 'Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens', 'orgStudyIdInfo': {'id': 'SBL-INI-02-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBL-3 multifocal intraocular lens', 'description': 'The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group', 'interventionNames': ['Device: SBL-3 multifocal intraocular lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control monofocal intraocular lens', 'description': 'The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group', 'interventionNames': ['Device: Control monofocal intraocular lens']}], 'interventions': [{'name': 'SBL-3 multifocal intraocular lens', 'type': 'DEVICE', 'description': 'The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group', 'armGroupLabels': ['SBL-3 multifocal intraocular lens']}, {'name': 'Control monofocal intraocular lens', 'type': 'DEVICE', 'description': 'The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group', 'armGroupLabels': ['Control monofocal intraocular lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Eye Center South', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Shepard Eye Center', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Cape Coral Eye Center', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Centers of Florida', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33870', 'city': 'Sebring', 'state': 'Florida', 'country': 'United States', 'facility': 'Newsom Eye & Laser Center', 'geoPoint': {'lat': 27.49559, 'lon': -81.44091}}, {'zip': '56201', 'city': 'Willmar', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Family Eye Centers', 'geoPoint': {'lat': 45.12191, 'lon': -95.04334}}, {'zip': '17810', 'city': 'Allenwood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Eye Center of Central PA', 'geoPoint': {'lat': 41.10758, 'lon': -76.8983}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Eye Care Specialists', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eyecare Physicians', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Loden Vision Center', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '76018', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Kleiman/Evangelista Eye Center', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Whitsett Vision Group', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The Eye Institute of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Blake Harris', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lenstec Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lenstec Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}