Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 4:46 AM
Study NCT ID:
NCT01142960
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2010-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'C500223', 'term': 'lycium barbarum polysaccharide'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Opacity Classification System III (LOCSIII)', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lens Opacity']}, 'descriptionModule': {'briefSummary': 'With the rapid growing aging population, age-related eye diseases including cataract are becoming more prevalent. The demand for cataract surgery and post-surgical care posed enormous financial burdens to the government.\n\nLycium barbarum contains lutein and zeaxanthin which can filter the phototoxic blue light and neutralize the reactive oxygen species, thus provide a protective effect against cataract formation.\n\nThis study aims to determine the effects of Lycium barbarum Supplements on the progression of senile cataract in Hong Kong Chinese elderly.', 'detailedDescription': 'Please note that a manuscript for this study is being prepared. Detailed description will be provided after we come up with the final draft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unlikely to have cataract surgery within 3 years\n* Presence of mild to moderate cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).\n* logMAR acuity equivalent to Snellen acuity of 20/63 or better\n* no previous history and clinical signs of glaucoma by determining intraocular pressure using applanation Tonometry (no more than 22mmHg)\n* no ocular anomalies: amblyopia, binocular anomalies, ocular trauma\n* no history of eye surgery, laser treatment, iritis, retinal crystalline deposits, macular degeneration, or optic nerve diseases\n* no extended use of systemic or ocular corticosteroid drugs\n* no concurrent participation of other systemic or ocular drug intervention study\n\nExclusion Criteria:\n\n* diabetes mellitus\n* renal failure\n* fat malabsorption syndrome\n* intestinal surgery history\n* chronic diarrhea\n* alcoholism\n* use of anticoagulants\n* regular use of nutritional supplements such as multi-vitamin, mineral and other antioxidant supplements (including Omega-3)'}, 'identificationModule': {'nctId': 'NCT01142960', 'briefTitle': 'Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population', 'orgStudyIdInfo': {'id': '5-ZH73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Starch', 'interventionNames': ['Dietary Supplement: Starch']}, {'type': 'EXPERIMENTAL', 'label': 'Lycium Barbarum', 'description': 'Lycium Barbarum supplement', 'interventionNames': ['Dietary Supplement: Lycium Barbarum']}], 'interventions': [{'name': 'Starch', 'type': 'DIETARY_SUPPLEMENT', 'description': '1350mg/day', 'armGroupLabels': ['Placebo']}, {'name': 'Lycium Barbarum', 'type': 'DIETARY_SUPPLEMENT', 'description': '1350mg/day', 'armGroupLabels': ['Lycium Barbarum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hung Hom', 'state': 'Kowloon', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.30715, 'lon': 114.18532}}], 'overallOfficials': [{'name': 'Chi-wai Do, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}, {'name': 'Chea-su Kee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hong Kong Jockey Club Charities Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chea-su Kee', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}