NCT03001258

Brief Summary

Demand in near vision correction in the community exist in the Bangladesh with a thin presence of eye- care. This study aimed to test the skill of BRAC service-providers in identifying presbyopia-cases, to ensure frequent services, meeting the community need. This was non-inferiority equivalence randomized intervention trial, done during February-June 2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya- shebikas (SS), were assigned to three different arms consisting two sub-districts through permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm. Sensitivity and specificity was calculated to understand screening performance. Screening reports were matched with the gold standard by recruiting refractionists.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

December 16, 2016

Results QC Date

January 3, 2017

Last Update Submit

March 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Screening Accuracy

    The outcome was considered as accurate and coded as "1" if the screening result agreed with the gold standard. That is, if the screening result is positive for presbyopia and the refractionist also reported it as positive or the screening result is negative and the refractionist also reported as negative.

    The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period

Study Arms (3)

PO (program organizers)

PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. Thus a total of 40 eye camps were held in two sub districts by eight POs.

Other: Presbyopia screening training

USS (Upgraded Shashthya Shebika)

USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided. In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps.

Other: Presbyopia screening training

SS (Shashthya Shebika)

SS: Community health workers of Brac. A two day presbyopia screening training were provided. In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.

Other: Presbyopia screening training

Interventions

The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity

PO (program organizers)SS (Shashthya Shebika)USS (Upgraded Shashthya Shebika)

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community people aged 35 or more, both male or female and having difficulty with near vision were invited for screening.

You may qualify if:

  • Aged 35 or more and have problem seeing close objects

You may not qualify if:

  • Individuals having diagnosed eye diseases that require regular treatment and was not willing to participate in the study were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Anita Sharif Chowdhury/Research Fellow of BRAC Research and Evaluation Division
Organization
BRAC

Study Officials

  • Anita Chowdhury, MPH

    Brac

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 23, 2016

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 21, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-03