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
|Condition or disease||Intervention/treatment||Phase|
|Cataract Surgery||Drug: Phacolin eye drops Procedure: cataract surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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).
- usual activities
- anxiety/depression f: self-rated health
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020056
|Huidong people's hospital|
|Huidong, Guangdong, China, 516300|
|Principal Investigator:||Yizhi Liu, Doctor||Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Study Director:||Yingfeng Zheng, Doctor||Zhongshan Ophthalmic Center, Sun Yat-sen University|