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

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phacolin eye drops
cataract surgery
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery focused on measuring cataract surgery, socioeconomic status, quality of life, rural area, China, randomized controlled trial

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Huidong people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

waiting surgery

expedited surgery

Arm Description

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

Cataract surgery will be performed within 4 weeks.

Outcomes

Primary Outcome Measures

annual personal income by work in Chinese Yuan
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

Health-related quality of life score
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
Vision related quality of life score
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

Full Information

First Posted
November 26, 2016
Last Updated
March 29, 2021
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03020056
Brief Title
Impact of Cataract Surgery to Socioeconomic Status in Rural Area
Acronym
ICSSES
Official Title
Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
cataract surgery, socioeconomic status, quality of life, rural area, China, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
waiting surgery
Arm Type
Placebo Comparator
Arm Description
Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).
Arm Title
expedited surgery
Arm Type
Experimental
Arm Description
Cataract surgery will be performed within 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Phacolin eye drops
Other Intervention Name(s)
antioxidant eye drops
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
cataract surgery
Other Intervention Name(s)
phacoemulsification or MSICS
Intervention Description
After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
Primary Outcome Measure Information:
Title
annual personal income by work in Chinese Yuan
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Health-related quality of life score
Description
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
Time Frame
1 year
Title
Vision related quality of life score
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, Doctor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yingfeng Zheng, Doctor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Huidong people's hospital
City
Huidong
State/Province
Guangdong
ZIP/Postal Code
516300
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Cataract Surgery to Socioeconomic Status in Rural Area

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