Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00285

2 Trial Registration Date

2011-11-28

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Project Vision Charity Fund

5 Primary Sponsor

Nil
Nil

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms. Zhang Xiujuan

ii Address

UEC, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

iii Phone

62547605

iv Email

zhangxiujuan@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Lam Shun-chiu Dennis

ii Address

UEC, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

iii Phone

27623134

iv Email

dennislam_cu_res@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Interventions to promote cataract surgery in people with the operable cataract in a rural area, northwest of China: a randomized controlled study

10 Public Title

Interventions to promote cataract surgery in people with the operable cataract in a rural area, northwest of China: a randomized controlled study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Mainland China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-04-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cataract

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

We randomly divide these subjects with operable cataract identified in our cataract screening program but did not received cataract surgery into 4 groups.
Group 1, we provide education for cataract blindness and outcome of treatment;
Group 2, we provide education + completely free of surgery;
Group 3, we provide education + completely free of surgery + reimbursement of transportation;
Group 4, we provide education+ completely free of surgery + free to pick up to the surgical site

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

One month

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

 Subjects aged 50 or above living in rural districts of Pucheng county, Shaanxi Province ；and
 Subjects diagnosed with the operable cataract and cataract as the principle cause of visual impairment with VA less than 6/18; and
 Subjects not present to Pucheng county hospital in 3 month from the initial cataract screen .

ii Exclusion Criteria

Subjects who refuse participate the research

iii Age Minimum

50

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Factorial

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-04-11

21 Target Sample Size

400

22 Recruitment Status

Complete

23 Primary Outcome

The number of individuals willing to accept and refuse cataract surgery will be addressed

24 Secondary Outcome

The factors preventing the subjects with visual impaired cataract from presenting for surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-12-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001783

28 Date of Registration in Primary Registry

2011-12-12

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-12-20