NCT01142960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

June 10, 2010

Last Update Submit

May 10, 2016

Conditions

Lens Opacity

Outcome Measures

Primary Outcomes (1)

  • Lens Opacity Classification System III (LOCSIII)

    3 years

Secondary Outcomes (1)

  • Visual Acuity

    3 years

Study Arms (2)

Placebo

ACTIVE COMPARATOR

Starch

Dietary Supplement: Starch

Lycium Barbarum

EXPERIMENTAL

Lycium Barbarum supplement

Dietary Supplement: Lycium Barbarum

Interventions

StarchDIETARY_SUPPLEMENT

1350mg/day

Placebo
Lycium BarbarumDIETARY_SUPPLEMENT

1350mg/day

Lycium Barbarum

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, 0000, Hong Kong

Location

MeSH Terms

Conditions

Cataract

Interventions

Starchlycium barbarum polysaccharide

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Chi-wai Do, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • Chea-su Kee, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 14, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

HK(1)