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

Lens Opacity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01142960
• Other study ID #: 5-ZH73
• Status: Not yet recruiting
• Phase: N/A
• First received: June 10, 2010
• Last updated: June 11, 2010
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2010
• Source: The Hong Kong Polytechnic University
• Contact: Chi-wai Do, PhD
• Phone: 27666090
• Email: socwdo[@]inet.polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Vitamin C, also known as ascorbate, is a highly effective antioxidant which may help to protect the cells including the crystalline lens components from oxidative damage, which is believed to be one of the causes of senile cataract.

Lycium barbarum, on the other hand, 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 Vitamin C and Lycium barbarum Supplements on the progression of senile cataract in Hong Kong Chinese elderly.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lens Opacity

Intervention

Dietary Supplement:
• Starch
1350mg/day
• Vitamin C
500mg Vitamin C plus 850mg Starch/day
• Lycium Barbarum
1350mg/day

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Opacity Classification System III (LOCSIII)		3 years	No
Secondary	Visual Acuity		3 years	No