Impact of Cataract Surgery to Socioeconomic Status in Rural Area (ICSSES)

Sun Yat-sen University

Status: Completed

Conditions: Cataract Surgery

Treatments: Drug: Phacolin eye drops; Procedure: cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03020056

2016KYYJ007

Details and patient eligibility

About

This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.

Full description

Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.

In the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed.

Enrollment: 292 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.

Exclusion criteria

• History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
• Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.
• Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.
• Patients not willing to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups, including a placebo group

waiting surgery

Placebo Comparator group

Description:

Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).

Treatment:

Drug: Phacolin eye drops

expedited surgery

Experimental group

Description:

Cataract surgery will be performed within 4 weeks.

Treatment:

Procedure: cataract surgery