Clinical trial NCT03020056: Impact of Cataract Surgery to Socioeconomic Status in Rural Area
Official title: Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Keywords: cataract surgery
socioeconomic status
quality of life
rural area
China
randomized controlled trial
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 292
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: annual personal income by work in Chinese Yuan
timeFrame: 1 year
Secondary outcomes:
measure: Health-related quality of life score
timeFrame: 1 year
measure: Vision related quality of life score
timeFrame: 1 year
Other outcomes:
Locations:
city: Huidong
country: China
facility: Huidong people's hospital
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yingfeng Zheng, Doctor
role: STUDY_DIRECTOR
References: