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Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population

This study has been completed.
Sponsor:
Collaborator:
The Hong Kong Jockey Club Charities Trust
Information provided by (Responsible Party):
Chea-su Kee, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01142960
First received: June 10, 2010
Last updated: May 10, 2016
Last verified: May 2016
  Purpose

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.

Lycium 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.

This study aims to determine the effects of Lycium barbarum Supplements on the progression of senile cataract in Hong Kong Chinese elderly.


Condition Intervention
Lens Opacity
Dietary Supplement: Starch
Dietary Supplement: Lycium Barbarum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Lens Opacity Classification System III (LOCSIII) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo
Starch
Dietary Supplement: Starch
1350mg/day
Experimental: Lycium Barbarum
Lycium Barbarum supplement
Dietary Supplement: Lycium Barbarum
1350mg/day

Detailed Description:
Please note that a manuscript for this study is being prepared. Detailed description will be provided after we come up with the final draft.
  Eligibility

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unlikely to have cataract surgery within 3 years
  • Presence of mild to moderate cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
  • logMAR acuity equivalent to Snellen acuity of 20/63 or better
  • no previous history and clinical signs of glaucoma by determining intraocular pressure using applanation Tonometry (no more than 22mmHg)
  • no ocular anomalies: amblyopia, binocular anomalies, ocular trauma
  • no history of eye surgery, laser treatment, iritis, retinal crystalline deposits, macular degeneration, or optic nerve diseases
  • no extended use of systemic or ocular corticosteroid drugs
  • no concurrent participation of other systemic or ocular drug intervention study

Exclusion Criteria:

  • diabetes mellitus
  • renal failure
  • fat malabsorption syndrome
  • intestinal surgery history
  • chronic diarrhea
  • alcoholism
  • use of anticoagulants
  • regular use of nutritional supplements such as multi-vitamin, mineral and other antioxidant supplements (including Omega-3)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142960

Locations
Hong Kong
The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong, 0000
Sponsors and Collaborators
The Hong Kong Polytechnic University
The Hong Kong Jockey Club Charities Trust
Investigators
Principal Investigator: Chi-wai Do, PhD The Hong Kong Polytechnic University
Principal Investigator: Chea-su Kee, PhD The Hong Kong Polytechnic University
  More Information

Responsible Party: Chea-su Kee, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01142960     History of Changes
Other Study ID Numbers: 5-ZH73 
Study First Received: June 10, 2010
Last Updated: May 10, 2016
Health Authority: Hong Kong: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 28, 2016