Evaluating the socioeconomic impact of cataract surgery for elderly patients in China

ISRCTN ISRCTN10552319
DOI https://doi.org/10.1186/ISRCTN10552319
Secondary identifying numbers 39156
Submission date
19/12/2016
Registration date
06/01/2017
Last edited
23/12/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Cataracts are cloudy areas on the lens of the eye. They can appear for a number of reasons however they are most common in older people, developing over a long period of time (senile cataract). The lens sits near the front of the eye, and plays an important role in vision. When cataracts cause the lens to become clouded, it can prevent light from reaching the back of the eye (retina) to form an image that can be interpreted by the brain. When this happens, vision becomes blurred and distorted, and can eventually lead to blindness. In many cases, the only effective treatment is to undergo cataract surgery, which involves removing the affected lens and replacing it with a clear artificial one (intraocular lens). Un-operated cataract remains the leading cause of blindness in China, and China’s cataract surgical rate (CSR) of 1000/million/year is lower than that of neighboring countries such as Vietnam (2000) and India (5500). This problem is particularly bad in rural (countryside) areas. The aim of this study is to investigate the socioeconomic (social and financial) impact of receiving free cataract surgery.

Who can participate?
Adults aged 40 years and over living in Handan County, China with poor vision in one eye due to cataracts that have not been operated on.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive cataract surgery immediately. Those in the second group are placed on a waiting list to receive cataract surgery a year later. At the start of the study and then after one year, participants in both groups complete a number of questionnaires designed to measure their household income, whether they are working and their wellbeing.

What are the possible benefits and risks of participating?
Participants who receive the surgery immediately will benefit from an improved ability to see clearly. There are no notable risks involved with participating other than the general risks of undergoing eye surgery.

Where is the study run from?
Shaanxi Normal University (China)

When is the study starting and how long is it expected to run for?
September 2016 to January 2018

Who is funding the study?
Stanford University (USA)

Who is the main contact?
Mr Matthew Boswell

Contact information

Mr Matthew Boswell
Public

Stanford University
Encina Hall E501
616 Serra Street
Stanford
94305
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSocioeconomic Impact of Cataract Surgery for Elderly Patients in China: Results from a Randomized Trial
Study acronymHandan Cataracts Study
Study objectivesThe aim of this study is to measure the impact of cataract surgery on key household socioeconomic outcomes such as income and labor market participation.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCataracts
InterventionParticipants are randomised to one of two groups based on baseline characteristics.

Intervention group: Participants undergo cataract surgery in February 2017. This involves small incision manual cataract surgery performed by an experienced surgeon with insertion of an appropriate intra-ocular lens, power to be determined in standard fashion by measurement of corneal curvature, axial length and refractive power in the operative and non-operative eyes.

Control group: Participants are placed on a wait-list and receive their cataract surgery in February 2018 after the collection of the final outcome measures.

Participants in both groups are followed up in standard fashion by an ophthalmologist from Tongren Hospital and complete follow up surveys after one year.
Intervention type
Primary outcome measure1. Household income is measured using the Handan Cataract Study Household Socioeconomic Survey at baseline and 12 months
2. Household member time allocation is measured using the Handan Cataract Study Household Socioeconomic Survey at baseline and 12 months
3. Household member labor market participation is measured using the Handan Cataract Study Household Socioeconomic Survey at baseline and 12 months
Secondary outcome measures1. Household member educational outcomes are measured using the Handan Cataract Study Household Socioeconomic Survey at baseline and 12 months
2. Household member subjective wellbeing is measured using the Handan Cataract Study Household Socioeconomic Survey at baseline and 12 months
Overall study start date30/09/2016
Completion date30/01/2018

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. LogMAR vision ≥ 0.5 in the better-seeing eye due to un- operated cataract identified in the original Handan Eye Study (2012)
2. Resident of Handan County, China
3. Aged 40 years and over
Key exclusion criteria1. Unwilling to give consent or unable to be contacted
2. Other ocular or health conditions that contraindicate or prevent the patient from undergoing cataract surgery
Date of first enrolment30/01/2017
Date of final enrolment02/07/2017

Locations

Countries of recruitment

  • China

Study participating centre

Shaanxi Normal University
Shaanxi
Xi'an
710119
China

Sponsor information

Stanford University
University/education

450 Serra Mall
Stanford
94305
United States of America

ROR logo "ROR" https://ror.org/00f54p054

Funders

Funder type

University/education

Stanford University

No information available

Results and Publications

Intention to publish date30/01/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in one or more high-impact peer reviewed journals prior to one year following the conclusion of the trial.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Matthew Boswell (boswell@stanford.edu)