Condition category
Eye Diseases
Date applied
30/01/2015
Date assigned
19/03/2015
Last edited
18/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cataracts are cloudy patches that develop in the lens of your eye and can cause blurred or misty vision. In many cases, cataracts are age-related, appearing first when a person is in his or her 40s or 50s, but not affecting vision until after age 60. Cataract surgery is the only treatment available while medical treatment is often provided but has proven to be not very effective. A safe and effective new technique is needed to improve patients’ vision, especially for those with mild and moderate cataracts. Iontophoresis is a non-invasive technique in which a small electric current is applied to increase drug penetration into the tissues. The advantages are that it is easy to use and there are no systemic side effects. Based on the principle of iontophoresis, Suzhou Liu Liuliu Vision Science and Technology Co. developed a method to deliver traditional Chinese medicine with the iontophoresis device. Early results show that vision is improved after 4 weeks application of the treatment. The device has recently been approved by the Chinese FDA. The aim of this study is to evaluate the effectiveness and safety of iontophoresis in combination with traditional Chinese medicine in patients with age-related cataracts.

Who can participate?
Adults aged between 65 and 80 with age-related cataracts in both eyes and without any history of eye surgery or laser treatment.

What does the study involve?
Participants will be randomly assigned to receive either iontophoresis combined with traditional Chinese medicine or placebo (sham) treatment. They will be followed up regularly for 4 weeks and during each visit there will be a series of vision assessments. The safety and effectiveness of iontophoresis will be estimated by changes in lens opacity, visual acuity, visual satisfaction and complications.

What are the possible benefits and risks of participating?
All of the participants in the study will receive a series of close follow-ups of their ocular health for 4 weeks with traffic subsidies. All of the participants will also receive an iontophoresis apparatus upon completion. The main benefit of iontophoresis is that it can potentially improve vision and reduce the density of cataract. The main risk of participating is that the Chinese medicine may cause an allergic reaction on the eyelids in some cases. In this case, it will not affect vision in the majority of cases, but severe allergy may require medical treatment.

Where is the study run from?
The study will be carried out at the Department of Preventive Ophthalmology, Zhongshan Ophthalmic Center (China).

When is the study starting and how long is it expected to run for?
Recruitment of the study started in December 2014. Each participant will be in the study for 4 weeks and the study is expected to run until May 2015.

Who is funding the study?
1. Zhongshan Ophthalmic Center, Department of Prevention Ophthalmology
2. Suzhou Liuliu Vision Science and Technology CO., LTD

Who is the main contact?
Mingguang He
mingguang_he@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Professor Mingguang He

ORCID ID

Contact details

54,Xianlie S Road,Yuexiu
Guangzhou
510060
China
+86 (0)20 87331109
mingguang_he@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy and safety of iontophoresis in patients with age-related cataract: a single-center, randomized, double-masked, controlled trial

Acronym

Study hypothesis

Patients with age-related cataract can obtain a better visual function after iontophoresis treatment.

Ethics approval

All procedures in this study adhered to the tenets of the Declaration of Helsinki and were approved by the Research Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-Sen University, China, 27/01/2014, certification number 2013MEKY031

Study design

Randomized double-blinded placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Age-related cataract

Intervention

Experimental arm: Use energized iontophoresis therapeutic apparatus combined with traditional Chinese medicine eye patch 30 minutes a day for 4 weeks.
Controlled arm: Use non-energized iontophoresis therapeutic apparatus combined with placebo eye patch 30 minutes a day for 4 weeks.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Change of uncorrected visual acuity, measured by ETDRS chart at baseline, 1 week, 2 weeks, 3 weeks and 4 weeks
2. Change of best-corrected visual acuity, measured by ETDRS chart at baseline, 1 week, 2 weeks, 3 weeks and 4 weeks
3. LOCS III lens opacity grading, measured by slit-lamp examination at baseline, 2 weeks and 4 weeks

Secondary outcome measures

1.​ Photographic evaluation of a change from baseline in nuclear, cortical, or posterior subcapsular cataract opacity grades, measured according to LOCSIII at baseline, 2 weeks and 4 weeks
2. Lens density varies during 4 weeks follow-up measured by Pentacam at baseline, 2 weeks and 4 weeks
3.​ Adverse events within 4 weeks associated with iontophoresis and traditional Chinese medicine.
4.​ Visual satisfaction, measured by questionnaire at 4 weeks

Overall trial start date

01/01/2014

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. ​Adults between the ages of 65 and 80 years old
2.​ LOCS III nuclear opalescence score >=3.0 OR cortical cataract score >=3.0 OR posterior subcapsular score >=1.0 bilateral
3.​ Able to commit to the 4-week follow up
4. ​Able to understand and sign an informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

118

Participant exclusion criteria

1.​ Types of cataracts other than age-related, including metabolic cataract, drugs and toxic cataract, congenital cataract, etc
2. ​Any other ocular pathology that may affect visual acuity, such as glaucoma, uveitis and retinopathy, etc
3.​ Patients with inflammation of the ocular surface and the adjacent area
4.​ History of ocular surgery or laser
5. ​Patients who are blind in one eye
6. ​Patients with uncontrolled systemic disease, i.e. high blood pressure (Bp > 160/100 mmHg), diabetes mellitus (GLU-AC >8mg/dl), kidney disease, etc

Recruitment start date

01/12/2014

Recruitment end date

18/02/2015

Locations

Countries of recruitment

China

Trial participating centre

Zhongshan Ophthalmic Center
54, Xianlie S Road
Guangzhou
510060
China

Sponsor information

Organisation

Zhongshan Ophthalmic Center, Department of Prevention Ophthalmology

Sponsor details

54
Xianlie S Road
Yuexiu
Guangzhou
510060
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Zhongshan Ophthalmic Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Suzhou Liuliu Vision Science and Technology CO., LTD

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes