Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-04-21 @ 12:33 PM
Study NCT ID:
NCT02131194
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2014-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Post-Vitrectomy Lenstatin™ Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564596', 'term': 'Cataract, Nuclear Progressive'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-05-02', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pentacam Nuclear Density Measurements', 'timeFrame': '(6) months', 'description': 'The endpoint for determining the efficacy of Lenstatin in inhibiting cataract growth is a 95% confidence level of a statistically significant greater than 5% reduction in the rate of of increase in Pentacam nuclear density measurements in the Lenstatin™ treatment group compared to the placebo treatment group at 6 months postoperative pars plana vitrectomy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract', 'Nutritional Supplement'], 'conditions': ['Cataract, Nuclear Progressive']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.', 'detailedDescription': 'BACKGROUND AND RATIONALE\n\nThere are conflicting reports on the effectiveness of nutritional antioxidants in preventing or slowing the growth of age related cataracts, despite extensive laboratory evidence suggesting that oxidative damage to lens epithelial cells is a common underlying etiologic factor in cataractogenesis. One reported review of nine clinical trials involving over 117,000 patients suggested that beta-carotene, Vitamin E, and Vitamin C had no effect in preventing or slowing the progression of age-related cataract. Conversely, a randomized trial of over 14,000 US male physicians indicated that long-term daily multivitamin use modestly and significantly decreased the risk of cataract.\n\nCataract formation following pars plana vitrectomy is a well recognized post-operative complication of the procedure, with the reported incidence of clinically significant cataract development as high as 80% within 2 years after pars plana vitrectomy.\n\nINVESTIGATIONAL AGENT\n\nLenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients and anti-oxidants intended to be taken for the nutritional support of the human crystalline lens.\n\nINTERVENTION\n\nParticipants will be randomized to treatment with Lenstatin or Placebo for (6) months following pars plana vitrectomy.\n\nSTUDY METHODS\n\nParticipants will have baseline nuclear density (cataract) measurements using the Pentacam Nucleus Staging (PNS) program. The Pentacam Scheimpflug imaging system is a non-contact and non-invasive anterior segment imaging device which has been shown to provide an immediate, quantitative, examiner-independent measurement of lens density which correlates with the LOCS III cataract grade. Serial Pentacam nuclear density measurements will be taken on each participant at (1) month intervals for (6) months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18\n* Post pars plana vitrectomy surgery\n\nExclusion Criteria:\n\n* Pediatric patients under the age of 18\n* Pregnant women\n* Hypersensitivity to any of the ingredients in Lenstatin'}, 'identificationModule': {'nctId': 'NCT02131194', 'briefTitle': 'The Post-Vitrectomy Lenstatin™ Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lenstatin LLC'}, 'officialTitle': 'The Post-Vitrectomy Lenstatin Study: A Prospective Randomized Double Blind Human Clinical Trial Testing the Efficacy of Lenstatin in Inhibiting Cataract Formation and Progression After Pars Plana Vitrectomy', 'orgStudyIdInfo': {'id': '1-tunis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenstatin', 'description': 'Lenstatin (2) capsules orally per day for (6) months', 'interventionNames': ['Dietary Supplement: Lenstatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'Placebo manufactured to mimic Lenstatin (2) capsules orally per day for (6) months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lenstatin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary Supplement Lenstatin', 'armGroupLabels': ['Lenstatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo sugar pill manufactured to mimic Lenstatin', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28405', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Scott W. Tunis MD FACS', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'Scott W Tunis, MD FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lenstatin LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lenstatin LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}