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.: PACTR201401000743135 Date of Approval: 14/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomised controlled trial of Bilamellar Tarsal Rotation (BLTR) verses Posterior Lamellar Tarsal Rotation (PLTR) surgery for trachomatous trichiasis
Official scientific title Randomised controlled trial of Bilamellar Tarsal Rotation (BLTR) verses Posterior Lamellar Tarsal Rotation (PLTR) surgery for trachomatous trichiasis and trichiasis surgery impact study
Brief summary describing the background and objectives of the trial Trachoma is the leading infectious cause of blindness worldwide. It begins in childhood with recurrent conjunctival Chlamydia trachomatis infection, which causes chronic inflammation. The inflammation results in conjunctival scarring (TS) trichiasis (TT), the in-turning of eyelashes, and sight loss from corneal opacification (CO). About 1.3 million people are blind and 6 million severely visually impaired from trachoma. Eight million have un-treated trichiasis. The WHO recommends surgery for trichiasis to reduce the risk of blindness using one of two procedures: Bilamellar Tarsal Rotation (BLTR) and Posterior Tarsal Rotation (PLTR). However, despite being a WHO priority research question, these alternative procedures have not been adequately compared; it is unknown which provides the best results under operational conditions. Currently both of these operations are widely used in Ethiopia. In this prospective, double-masked randomised controlled trial, BLTR will be compared with to PLTR in Amhara Region, Ethiopia. The primary outcome will be recurrent TT by one year. Trichiasis cases (1000) will be randomly allocated to either BLTR or PLTR surgery. Follow-up assessments will take place at 6 and 12 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery,Trachoma, Trichiasis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 22/01/2014
Actual trial start date 03/02/2014
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 04/05/2015
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1000
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
6428 London School of Hygiene and Tropical Medicine
3.10/573/06 National Research Ethics Review Committee, Ministry of Science and Technology, Ethiopia
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 Sequence was generated by an independent statitician by computer. Each surgeon operating on patients with trichiasis has a seperate sequence. The sequnce is blocked with a variable block size of 4 or 6. computer. The allocation was conceled in sequentially numbered, sealed, opaque envelopes. The master list sequence is held securly by an independent statitician. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilamellar Tarsal Rotation Surgery (BLTR) Surgery performed once at recruitment Standard BLTR Surgery performed as per the WHO approved procedure 500
Experimental Group Posterior Lamellar Tarsal Rotation Surgery (PLTR) Surgery performed once at recruitment Standard BLTR Surgery performed as per the WHO approved procedure 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Case Definition: Trachomatous Trichiasis cases in this study will be defined as: individuals with one or more eyelashes touching the eyeball or with evidence of epilation in either or both of the eyes, and tarsal conjunctival scarring. Inclusion criteria: 1. Trachomatous Trichiasis with tarsal conjunctival scarring 2. Adults (¿18 years) 3. Agree to be randomly allocated to one of the two alternative operative procedures 4. Agree to re-examination at six and twelve months after surgery Exclusion Criteria: 1. Age less than 18 years 2. Previous eyelid surgery 3. Medically unfit, BP systolic >170, diastolic >110. 4. Pregnant 5. Patients with trichiasis from other eyelid pathologies 18 Year(s) 100 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 13/12/2013 National Research Ethics Review Committee, Ministry of Science and Technology
Ethics Committee Address
Street address City Postal code Country
PO BOX 2490 Addis Ababa Ethiopia
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 London School of Hygiene and Tropical Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure: recurrent trichiasis, defined as one or more lashes touching the eye or clinical evidence of epilation at either the six or twelve month assessments or a history of repeat surgery during the last one year after the baseline surgery Six Months One Year
Secondary Outcome Secondary outcome measures: (1) Severity of recurrent trichiasis (number of lashes) and entropion, (2) Change in corneal opacification (by comparison of photographs), (3) Change in visual acuity (LogMAR), (4) Conjunctival inflammation, (5) Complication rates Six Months One YEar
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Carter Center Trachoma Control Program PO Box Bahir Dar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Wellcome Trust Euston Road London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Amhara Regional Health Bureau Bahir Dar Ethiopia
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
The Carter Center Atlanta United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Burton matthew.burton@lshtm.ac.uk +44 (0)20 7927 2329 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Matthew Burton matthew.burton@lshtm.ac.uk +44 (0)20 7927 2329 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Matthew Burton matthew.burton@lshtm.ac.uk +44 (0)20 7927 2329 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom
REPORTING
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