Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201538166596 Date of Approval: 21/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community-Led intervention to increase Cataract Surgery Uptake: What will Community Decide?
Official scientific title Alternative Community-led intervention to improve uptake of cataract surgery services in rural Tanzania- The Dodoma Community Cataract Acceptance Trial (DoCCAT)
Brief summary describing the background and objectives of the trial The latest World Report on Vision stated that, globally, at least 2.2 billion people have a vision impairment or blindness, of whom at least 1 billion have a vision impairment that could have been prevented or has yet to be addressed. The age-standardized prevalence of blindness was highest in western sub-Saharan Africa, eastern sub-Saharan Africa, and South Asia. The study also found that, in all world regions, women bear the majority of blindness and vision impairment. In low-and middle-income countries, where cataract is the leading cause of blindness, women do not get to access surgical services with the same frequency as men. Several studies have shown that the cataract surgical coverage among women in sub-Saharan Africa (SSA) and South Asia is nearly always lower, sometimes only half that in men. The main goal of this trial is to evaluate the efficacy of a community-based intervention to improve access to cataract surgery services in rural Tanzania, with specific emphasis on the ability to improve gender equity in access to care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DoCCAT
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 07/08/2025
Actual Last follow-up date 10/10/2025
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
Publication URL www.udom.ac.tz
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard Eye Screening Ongoing None 2 Years None 40 Uncontrolled
Experimental Group Community Led Intervention Once 2 Years The Community will determine what will work the best and then implemented it as an Intervention in Selected wards. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All aged 50 years and above Cataract Disease Pseudophakia Mental issues Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 150 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/07/2021 NIMR
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Attendance at outreach sites, Surgery Acceptance rate At the End of the Trial
Secondary Outcome Reason for not attending and refusals At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dodoma Dodoma Dodoma 2716 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Lions international USA USA USA United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lions Club International Sight Grant 300W, 22nd Street Ilinois Oak Brook United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Robert Geneau SA Cape town SA South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frank Sandi franktheson@live.com +255713690056 UDOM
City Postal code Country Position/Affiliation
Dodoma 2716 United Republic of Tanzania Clinical Instructor and Researcher
Role Name Email Phone Street address
Public Enquiries Robert Geneau rgeneau@kcco.net +18196356730 Cape town
City Postal code Country Position/Affiliation
Cape Twon 124 South Africa University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Gareth Mercer Gareth.mercer@mail.mcgill.ca +255713690056 Canada
City Postal code Country Position/Affiliation
McGill 23667 Canada Fellow at MCGill
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study has not yet started but IPD will be included. Study Protocol 10 Months After Study Completion After Study ending
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.udom.ac.tz No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information