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

Primary Purpose

Lens Opacity

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Starch
Lycium Barbarum
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lens Opacity

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo

Lycium Barbarum

Arm Description

Starch

Lycium Barbarum supplement

Outcomes

Primary Outcome Measures

Lens Opacity Classification System III (LOCSIII)

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
June 10, 2010
Last Updated
May 10, 2016
Sponsor
The Hong Kong Polytechnic University
Collaborators
The Hong Kong Jockey Club Charities Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01142960
Brief Title
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
Official Title
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The Hong Kong Jockey Club Charities Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lens Opacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Starch
Arm Title
Lycium Barbarum
Arm Type
Experimental
Arm Description
Lycium Barbarum supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Starch
Intervention Description
1350mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycium Barbarum
Intervention Description
1350mg/day
Primary Outcome Measure Information:
Title
Lens Opacity Classification System III (LOCSIII)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-wai Do, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chea-su Kee, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
State/Province
Kowloon
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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