Lens OpacityNCT01142960
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
A study testing Starch and Lycium Barbarum in people with Lens Opacity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lens Opacity
- What is being tested?
- Starch and Lycium Barbarum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Hung Hom, Kowloon, 0000
About this study
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.
Read the 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.
- Conditions
- Lens Opacity
- Being tested
- Starch, Lycium Barbarum
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StarchDietary supplement
1350mg/day
Lycium BarbarumDietary supplement
1350mg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Starch Receives: Dietary Supplement: Starch |
| Lycium Barbarum | Experimental | Lycium Barbarum supplement Receives: Dietary Supplement: Lycium Barbarum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Opacity Classification System III (LOCSIII)
Measured: 3 years
Secondary outcomes (1)
Visual Acuity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens OpacityStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Responsible party
- Principal investigator, Chea-su Kee, The Hong Kong Polytechnic University
- Investigators
- Chi-wai Do, PhD, Principal investigator, The Hong Kong Polytechnic UniversityChea-su Kee, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142960
- Sponsor's protocol ID
- 5-ZH73
- Status last verified
- May 2016
- First submitted
- 10 Jun 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
- ClinicalTrials.gov ID
- NCT01142960
- Acronym / sponsor ID
- 5-ZH73
- Conditions
- Lens Opacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- Nov 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Dietary Supplement: StarchStarch |
| Lycium Barbarum | Experimental | Dietary Supplement: Lycium BarbarumLycium Barbarum supplement |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- diabetes mellitus
- renal failure
- fat malabsorption syndrome
- intestinal surgery history
- chronic diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch1350mg/day | Dietary supplement | Placebo |
| Lycium Barbarum1350mg/day | Dietary supplement | Lycium Barbarum |
Primary outcome
Lens Opacity Classification System III (LOCSIII)
Time frame: 3 years
1 secondary outcome
Visual Acuity
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: Undecided
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Intraocular Lens Complication, Intraocular Lens Rotation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-wai Do, PhD principal investigator
The Hong Kong Polytechnic University
Chea-su Kee, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starch and Lycium Barbarum in people with Lens Opacity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens Opacity Classification System III (LOCSIII) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.