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

May 10, 2016 updated by: Chea-su Kee, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Kowloon
      • Hung Hom, Kowloon, Hong Kong, 0000
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Placebo
Starch
Dietary supplement: Starch
1350mg/day
EXPERIMENTAL: Lycium Barbarum
Lycium Barbarum supplement
Dietary supplement: Lycium Barbarum
1350mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lens Opacity Classification System III (LOCSIII)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

The Hong Kong Jockey Club Charities Trust

Investigators

  • Principal Investigator: Chi-wai Do, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (ESTIMATE)

June 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-ZH73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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