Trial Outcomes & Findings for Presbyopia Screening by Community Health Worker in Bangladesh (NCT NCT03001258)

Last Updated: 2017-04-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2001 participants

Primary outcome timeframe

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

Results posted on

2017-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	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. A total of 40 eye camps were held in two sub districts by eight POs. Presbyopia screening training: 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 managemen	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. Presbyopia screening training: 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	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. Presbyopia screening training: 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
Overall Study STARTED	765	751	485
Overall Study COMPLETED	765	751	485
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

It is distribution of total population by customized age catagory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PO (Program Organizers) n=400 Participants PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. 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. A total of 40 eye camps were held in two sub districts by eight POs.	USS (Upgraded Shashthya Shebika) n=440 Participants USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided. 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps. 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.	SS (Shashthya Shebika) n=250 Participants 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. Presbyopia screening training: 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	Total n=1090 Participants Total of all reporting groups
Age, Customized <40	60 participants n=60 Participants • It is distribution of total population by customized age catagory	64 participants n=64 Participants • It is distribution of total population by customized age catagory	45 participants n=45 Participants • It is distribution of total population by customized age catagory	169 participants n=169 Participants • It is distribution of total population by customized age catagory
Age, Customized 40-44	126 participants n=126 Participants • It is distribution of total population by customized age catagory	146 participants n=146 Participants • It is distribution of total population by customized age catagory	52 participants n=52 Participants • It is distribution of total population by customized age catagory	324 participants n=324 Participants • It is distribution of total population by customized age catagory
Age, Customized 45-49	88 participants n=88 Participants • It is distribution of total population by customized age catagory	108 participants n=108 Participants • It is distribution of total population by customized age catagory	65 participants n=65 Participants • It is distribution of total population by customized age catagory	261 participants n=261 Participants • It is distribution of total population by customized age catagory
Age, Customized 50-54	67 participants n=67 Participants • It is distribution of total population by customized age catagory	64 participants n=64 Participants • It is distribution of total population by customized age catagory	47 participants n=47 Participants • It is distribution of total population by customized age catagory	178 participants n=178 Participants • It is distribution of total population by customized age catagory
Age, Customized ≥ 55	59 participants n=59 Participants • It is distribution of total population by customized age catagory	62 participants n=62 Participants • It is distribution of total population by customized age catagory	41 participants n=41 Participants • It is distribution of total population by customized age catagory	162 participants n=162 Participants • It is distribution of total population by customized age catagory
Sex: Female, Male Female	314 Participants n=400 Participants	385 Participants n=440 Participants	214 Participants n=250 Participants	913 Participants n=1090 Participants
Sex: Female, Male Male	86 Participants n=400 Participants	55 Participants n=440 Participants	36 Participants n=250 Participants	177 Participants n=1090 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	PO (Program Organizers) n=765 Participants PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. 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. A total of 40 eye camps were held in two sub districts by eight POs.	USS (Upgraded Shashthya Shebika) n=751 Participants USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided. 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps. 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	SS (Shashthya Shebika) n=485 Participants 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. Presbyopia screening training: 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
Screening Accuracy Sensitivity	76.9 percentage of cases Interval 72.6 to 80.8	75.7 percentage of cases Interval 71.8 to 79.3	58.1 percentage of cases Interval 52.8 to 63.3
Screening Accuracy Specificity	78.3 percentage of cases Interval 73.5 to 82.6	67.0 percentage of cases Interval 60.3 to 73.1	69.3 percentage of cases Interval 60.5 to 77.2
Screening Accuracy Positive Predictive Value	81.5 percentage of cases Interval 77.3 to 85.2	84.6 percentage of cases Interval 81.0 to 87.7	84.2 percentage of cases Interval 79.1 to 88.5
Screening Accuracy Negative Predictive Value	73.2 percentage of cases Interval 68.3 to 77.6	53.4 percentage of cases Interval 47.4 to 59.4	84.2 percentage of cases Interval 79.1 to 88.5
Screening Accuracy Accuracy	77.5 percentage of cases Interval 74.4 to 80.3	73.1 percentage of cases Interval 69.8 to 76.2	61.0 percentage of cases Interval 56.6 to 65.3
Screening Accuracy False Positive Rate	23.1 percentage of cases Interval 19.4 to 27.4	24.3 percentage of cases Interval 20.9 to 28.2	41.9 percentage of cases Interval 36.9 to 47.1
Screening Accuracy False Negative Rate	21.7 percentage of cases Interval 17.7 to 26.4	33.0 percentage of cases Interval 27.2 to 39.5	30.7 percentage of cases Interval 23.4 to 39.2

Adverse Events

PO (Program Organizers)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

USS (Upgraded Shashthya Shebika)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SS (Shashthya Shebika)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

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

BRAC

Phone: +88029846448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place