Efficacy and safety of iontophoresis in patients with age-related cataract

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34571027

Enrollment

118

Registered

2015-03-19

Start date

2014-12-01

Completion date

Unknown

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related cataract Eye Diseases Senile cataract

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026