Efficacy and safety of iontophoresis in patients with age-related cataract
| ISRCTN | ISRCTN34571027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34571027 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/01/2015
- Registration date
- 19/03/2015
- Last edited
- 14/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
54，Xianlie S Road，Yuexiu
Guangzhou
510060
China
| Phone | +86 (0)20 87331109 |
|---|---|
| mingguang_he@yahoo.com |
Study information
| Study design | Randomized double-blinded placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficacy and safety of iontophoresis in patients with age-related cataract: a single-center, randomized, double-masked, controlled trial |
| Study objectives | Patients with age-related cataract can obtain a better visual function after iontophoresis treatment. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 118 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2014 |
| Date of final enrolment | 18/02/2015 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou
510060
China
Sponsor information
Hospital/treatment centre
Department of Prevention Ophthalmology
54, Xianlie S Road
Yuexiu
Guangzhou
510060
China
"ROR" |
https://ror.org/0064kty71 |
|---|
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Editorial Notes
14/08/2020: No publications found.
