Skip to main content
OpenTrials
Completed

NCT Number: NCT03020056

Impact of Cataract Surgery to Socioeconomic Status in Rural Area

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huidong people's hospital

Huidong, Guangdong, 516300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phacolin eye drops

Drug

After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.

Other names: antioxidant eye drops

cataract surgery

Procedure

After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.

Other names: phacoemulsification or MSICS

Primary outcomes

  1. annual personal income by work in Chinese Yuan

    Time frame: 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 outcomes

  1. Health-related quality of life score

    Time frame: 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).

    • mobility
    • self-care
    • usual activities
    • pain/discomfort
    • anxiety/depression f: self-rated health
  2. Vision related quality of life score

    Time frame: 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).

    • reading text in the newspaper
    • recognizing faces of people you meet
    • seeing prices of goods when shopping
    • seeing to walk on uneven ground
    • seeing to do needlework and handicraft
    • reading text on television
    • seeing to carry out a preferred hobby
    • difficulty in daily life
    • satisfaction on present vision

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial

Acronym: ICSSES

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.