Impact of Cataract Surgery to Socioeconomic Status in Rural Area

Not Applicable

Completed

• Conditions: Cataract Surgery
• Interventions: Procedure: cataract surgery; Drug: Phacolin eye drops

• Registration Number: NCT03020056
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2016-11-26
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-01-16
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
expedited surgery	cataract surgery	Cataract surgery will be performed within 4 weeks.
waiting surgery	Phacolin eye drops	Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).

Primary Outcome Measures

Name	Time	Method
annual personal income by work in Chinese Yuan	1 year	The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life score	1 year	Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: "no problems" to 5: "unable to/extreme problems". Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state).; 1. mobility; 2. self-care; 3. usual activities; 4. pain/discomfort; 5. anxiety/depression f: self-rated health
Vision related quality of life score	1 year	Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty).; 1. reading text in the newspaper; 2. recognizing faces of people you meet; 3. seeing prices of goods when shopping; 4. seeing to walk on uneven ground; 5. seeing to do needlework and handicraft; 6. reading text on television; 7. seeing to carry out a preferred hobby; 8. difficulty in daily life; 9. satisfaction on present vision

Trial Locations

Locations (1)

Huidong people's hospital; 🇨🇳 Huidong, Guangdong, China