NCT03020056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

November 26, 2016

Last Update Submit

March 29, 2021

Conditions

Cataract Surgery

Keywords

cataract surgerysocioeconomic statusquality of liferural areaChinarandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Health-related quality of life score

    1 year

  • Vision related quality of life score

    1 year

Study Arms (2)

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).

Drug: Phacolin eye drops

expedited surgery

EXPERIMENTAL

Cataract surgery will be performed within 4 weeks.

Procedure: cataract surgery

Interventions

Phacolin eye dropsDRUG

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.

Also known as: antioxidant eye drops
waiting surgery
cataract surgeryPROCEDURE

After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.

Also known as: phacoemulsification or MSICS
expedited surgery

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huidong people's hospital

Huidong, Guangdong, 516300, China

Location

Related Publications (1)

  • 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.

    PMID: 37523426DERIVED

MeSH Terms

Interventions

Cataract ExtractionPhacoemulsification

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Yizhi Liu, Doctor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yingfeng Zheng, Doctor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor,director of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

November 26, 2016

First Posted

January 13, 2017

Study Start

January 16, 2017

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

CN(1)