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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| waiting surgery | Placebo Comparator | Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China). |
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| expedited surgery | Experimental | Cataract surgery will be performed within 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, Doctor | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Yingfeng Zheng, Doctor | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huidong people's hospital | Huidong | Guangdong | 516300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37523426 | Derived | Tan X, Han X, Zheng Y, Jin L, Qiu X, Zhu Y, Chen C, Zhang J, Dickey H, Wang D, Huang S, Liu B, Liang X, Zeng Y, Lin H, He M, Luo L, Huang W, Congdon N, Liu Y. Impact of Cataract Surgery on Income in Rural Southern China: The SUCCESS Randomized Controlled Trial. Asia Pac J Ophthalmol (Phila). 2023 Jul-Aug 01;12(4):355-363. doi: 10.1097/APO.0000000000000624. Epub 2023 Jul 21. |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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| cataract surgery | Procedure | After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks. |
|
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| 1 year |
| 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).
| 1 year |