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

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ClinicalTrials.gov Identifier: NCT03020056
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Yizhi Liu, 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.

Condition or disease Intervention/treatment Phase
Cataract Surgery Drug: Phacolin eye drops Procedure: cataract surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Placebo Comparator: waiting surgery
Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).
Drug: Phacolin eye drops
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 Name: antioxidant eye drops

Experimental: expedited surgery
Cataract surgery will be performed within 4 weeks.
Procedure: cataract surgery
After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
Other Name: phacoemulsification or MSICS




Primary Outcome Measures :
  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 Outcome Measures :
  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).

    1. mobility
    2. self-care
    3. usual activities
    4. pain/discomfort
    5. 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).

    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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020056


Locations
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China, Guangdong
Huidong people's hospital
Huidong, Guangdong, China, 516300
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Principal Investigator: Yizhi Liu, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Director: Yingfeng Zheng, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Yizhi Liu, Clinical Professor,director of Zhongshan Ophthalmic Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03020056     History of Changes
Other Study ID Numbers: 2016KYYJ007
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University:
cataract surgery
socioeconomic status
quality of life
rural area
China
randomized controlled trial
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Antioxidants
Pharmaceutical Solutions
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs