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Surgery Versus Epilation for the Treatment of Minor Trichiasis in Ethiopia: A Randomised Controlled Noninferiority Trial

Publication Date: December 13, 2011
Journal: PLOS Medicine
Authors: Saul N. Rajak, Esmael Habtamu, Helen A. Weiss, Amir Bedri Kello, et al
Volume: 8
Issue: 12
Pages: e1001136
DOI: https://dx.plos.org/10.1371/journal.pmed.1001136
Publisher URL: http://journals.plos.org/plosmedicine/article?id=10.1371%2Fjournal.pmed.1001136
PubMed: http://www.ncbi.nlm.nih.gov/pubmed/22180731
PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3236738
Europe PMC: http://europepmc.org/abstract/MED/22180731
Web of Science: 000298668100001
Scopus: 84855169988
Mendeley: http://www.mendeley.com/research/surgery-versus-epilation-treatment-minor-trichiasis-ethiopia-randomised-controlled-noninferiority-tr

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{"title"=>"Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: A randomised controlled noninferiority trial", "type"=>"journal", "authors"=>[{"first_name"=>"Saul N.", "last_name"=>"Rajak", "scopus_author_id"=>"54879564900"}, {"first_name"=>"Esmael", "last_name"=>"Habtamu", "scopus_author_id"=>"39261595000"}, {"first_name"=>"Helen A.", "last_name"=>"Weiss", "scopus_author_id"=>"7403112967"}, {"first_name"=>"Amir Bedri", "last_name"=>"Kello", "scopus_author_id"=>"7801322801"}, {"first_name"=>"Teshome", "last_name"=>"Gebre", "scopus_author_id"=>"24472675600"}, {"first_name"=>"Asrat", "last_name"=>"Genet", "scopus_author_id"=>"23987844600"}, {"first_name"=>"Robin L.", "last_name"=>"Bailey", "scopus_author_id"=>"7402652011"}, {"first_name"=>"David C.W.", "last_name"=>"Mabey", "scopus_author_id"=>"56400433900"}, {"first_name"=>"Peng T.", "last_name"=>"Khaw", "scopus_author_id"=>"7006578947"}, {"first_name"=>"Clare E.", "last_name"=>"Gilbert", "scopus_author_id"=>"7201382726"}, {"first_name"=>"Paul M.", "last_name"=>"Emerson", "scopus_author_id"=>"7006957525"}, {"first_name"=>"Matthew J.", "last_name"=>"Burton", "scopus_author_id"=>"7202920109"}], "year"=>2011, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491277", "scopus"=>"2-s2.0-84855169988", "sgr"=>"84855169988", "pui"=>"364014900", "isbn"=>"1549-1676 (Electronic)\\r1549-1277 (Linking)", "pmid"=>"22180731", "doi"=>"10.1371/journal.pmed.1001136"}, "id"=>"8d91cef7-31b7-38b1-ab4e-e2e9eda3c281", "abstract"=>"BACKGROUND: Trachomatous trichiasis can cause corneal damage and visual impairment. WHO recommends surgery for all cases. However, in many regions surgical provision is inadequate and patients frequently decline. Self-epilation is common and was associated with comparable outcomes to surgery in nonrandomised studies for minor trichiasis (<six lashes touching eye). This trial investigated whether epilation is noninferior to surgery for managing minor trichiasis.\\n\\nMETHODS AND FINDINGS: 1,300 individuals with minor trichiasis from Amhara Regional State, Ethiopia were recruited and randomly assigned (1:1) to receive trichiasis surgery or epilation. The epilation group were given new forceps and epilation training. The surgical group received trichiasis surgery. Participants were examined every 6 months for 2 years by clinicians masked to allocation, with 93.5% follow-up at 24 months. The primary outcome measure (\"failure\") was ≥five lashes touching the eye or receiving trichiasis surgery during 24 months of follow-up, and was assessed for noninferiority with a 10% prespecified noninferiority margin. Secondary outcomes included number of lashes touching, time to failure, and changes in visual acuity and corneal opacity. Cumulative risk of failure over 24 months was 13.2% in the epilation group and 2.2% in the surgical group (risk difference = 11%). The 95% confidence interval (8.1%-13.9%) includes the 10% noninferiority margin. Mean number of lashes touching the eye was greater in the epilation group than the surgery group (at 24 months 0.95 versus 0.09, respectively; p<0.001); there was no difference in change in visual acuity or corneal opacity between the two groups.\\n\\nCONCLUSIONS: This trial was inconclusive regarding inferiority of epilation to surgery for the treatment of minor trichiasis, relative to the prespecified margin. Epilation had a comparable effect to surgery on visual acuity and corneal outcomes. We suggest that surgery be performed whenever possible but epilation be used for treatment of minor trichiasis patients without access to or declining surgery.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00522912.", "link"=>"http://www.mendeley.com/research/surgery-versus-epilation-treatment-minor-trichiasis-ethiopia-randomised-controlled-noninferiority-tr", "reader_count"=>46, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Librarian"=>1, "Researcher"=>8, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>7, "Student > Master"=>10, "Other"=>4, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>2, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Librarian"=>1, "Researcher"=>8, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>7, "Student > Master"=>10, "Other"=>4, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>2, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Environmental Science"=>1, "Nursing and Health Professions"=>3, "Medicine and Dentistry"=>30, "Agricultural and Biological Sciences"=>3, "Business, Management and Accounting"=>2, "Psychology"=>1, "Social Sciences"=>2, "Biochemistry, Genetics and Molecular Biology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>30}, "Social Sciences"=>{"Social Sciences"=>2}, "Psychology"=>{"Psychology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>3}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>3}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>3}, "Environmental Science"=>{"Environmental Science"=>1}}, "reader_count_by_country"=>{"Tanzania"=>1, "Kenya"=>1}, "group_count"=>5}

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{"referral"=>"http://blogs.plos.org/speakingofmedicine/?p=6061", "language"=>"English", "title"=>"Treating Trichiasis | Speaking of Medicine", "type"=>"Blog", "publication"=>"Speaking of Medicine", "published_on"=>"", "link_state"=>"APPROVED", "id"=>66034, "created"=>"2017-04-07T07:03:02.000Z", "crowdsourced"=>false, "article"=>{"id"=>21440, "doi"=>"10.1371/journal.pmed.1001136", "title"=>"<article-title xmlns:mml=\"http://www.w3.org/1998/Math/MathML\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">Surgery Versus Epilation for the Treatment of Minor Trichiasis in Ethiopia: A Randomised Controlled Noninferiority Trial</article-title>", "published_on"=>"2011-12-12T00:00:00.000Z"}}

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{"id"=>"306425136800751616", "text"=>"Surgery or epilation? Silk or absorbable sutures? for trachomatous trichiasis #trachoma http://t.co/6XuLRAOPbt & http://t.co/KVm6Ze6p2c", "created_at"=>"2013-02-26T15:27:00Z", "user"=>"PLOSMedicine", "user_name"=>"PLOS Medicine", "user_profile_image"=>"http://a0.twimg.com/profile_images/2436335697/k93oob5au2gllc775hk5_normal.jpeg"}

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Figshare 4814 Mar 14:14 UTC

Figshare

{"files"=>["https://ndownloader.figshare.com/files/703528"], "description"=>"<p>Trial profile.</p>", "links"=>[], "tags"=>["Infectious diseases", "ophthalmology", "surgery"], "article_id"=>373886, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.g001", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_/373886", "title"=>"Trial profile.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-12-13 01:04:46"}
{"files"=>["https://ndownloader.figshare.com/files/703819"], "description"=>"<p>CF, count fingers; HM, hand movements; PL, perception of light; NPL, no perception of light; VA, visual acuity.</p>", "links"=>[], "tags"=>["characteristics", "12", "24"], "article_id"=>374167, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.t002", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Clinical_characteristics_of_participants_in_each_arm_of_the_trial_at_12_and_24_mo_/374167", "title"=>"Clinical characteristics of participants in each arm of the trial at 12 and 24 mo.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-12-13 01:09:27"}
{"files"=>["https://ndownloader.figshare.com/files/356999", "https://ndownloader.figshare.com/files/357088", "https://ndownloader.figshare.com/files/357255"], "description"=>"<div><h3>Background</h3><p>Trachomatous trichiasis can cause corneal damage and visual impairment. WHO recommends surgery for all cases. However, in many regions surgical provision is inadequate and patients frequently decline. Self-epilation is common and was associated with comparable outcomes to surgery in nonrandomised studies for minor trichiasis ( </p><h3>Methods and Findings</h3><p>1,300 individuals with minor trichiasis from Amhara Regional State, Ethiopia were recruited and randomly assigned (1∶1) to receive trichiasis surgery or epilation. The epilation group were given new forceps and epilation training. The surgical group received trichiasis surgery. Participants were examined every 6 months for 2 years by clinicians masked to allocation, with 93.5% follow-up at 24 months. The primary outcome measure (“failure”) was ≥five lashes touching the eye or receiving trichiasis surgery during 24 months of follow-up, and was assessed for noninferiority with a 10% prespecified noninferiority margin. Secondary outcomes included number of lashes touching, time to failure, and changes in visual acuity and corneal opacity.</p> <p>Cumulative risk of failure over 24 months was 13.2% in the epilation group and 2.2% in the surgical group (risk difference = 11%). The 95% confidence interval (8.1%–13.9%) includes the 10% noninferiority margin. Mean number of lashes touching the eye was greater in the epilation group than the surgery group (at 24 months 0.95 versus 0.09, respectively; <em>p</em><0.001); there was no difference in change in visual acuity or corneal opacity between the two groups.</p> <h3>Conclusions</h3><p>This trial was inconclusive regarding inferiority of epilation to surgery for the treatment of minor trichiasis, relative to the prespecified margin. Epilation had a comparable effect to surgery on visual acuity and corneal outcomes. We suggest that surgery be performed whenever possible but epilation be used for treatment of minor trichiasis patients without access to or declining surgery.</p> <h3>Trial registration</h3><p><a href=\"http://ClinicalTrials.gov\">ClinicalTrials.gov</a><a href=\"http://clinicaltrials.gov/ct2/show/NCT00522912\">NCT00522912</a></p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["epilation", "trichiasis", "randomised", "controlled", "noninferiority"], "article_id"=>130545, "categories"=>["Medicine", "Cancer"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001136.s001", "https://dx.doi.org/10.1371/journal.pmed.1001136.s002", "https://dx.doi.org/10.1371/journal.pmed.1001136.s003"], "stats"=>{"downloads"=>2, "page_views"=>38, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Surgery_Versus_Epilation_for_the_Treatment_of_Minor_Trichiasis_in_Ethiopia_A_Randomised_Controlled_Noninferiority_Trial/130545", "title"=>"Surgery Versus Epilation for the Treatment of Minor Trichiasis in Ethiopia: A Randomised Controlled Noninferiority Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-12-13 00:09:05"}
{"files"=>["https://ndownloader.figshare.com/files/703954"], "description"=>"<p>Postsurgical complications (a) at 7–10-d follow-up and (b) at any subsequent follow-up.</p>", "links"=>[], "tags"=>["complications", "follow-up"], "article_id"=>374306, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.t004", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Postsurgical_complications_a_at_7_8211_10_d_follow_up_and_b_at_any_subsequent_follow_up_/374306", "title"=>"Postsurgical complications (a) at 7–10-d follow-up and (b) at any subsequent follow-up.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-12-13 01:11:46"}
{"files"=>["https://ndownloader.figshare.com/files/704003"], "description"=>"a<p>As recalled at 12 mo.</p>", "links"=>[], "tags"=>["reported", "12-", "24-mo"], "article_id"=>374350, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.t005", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Symptoms_reported_by_participants_at_12_and_24_mo_follow_ups_/374350", "title"=>"Symptoms reported by participants at 12- and 24-mo follow-ups.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-12-13 01:12:30"}
{"files"=>["https://ndownloader.figshare.com/files/703683"], "description"=>"<p>Kaplan Meier graph of time to failure.</p>", "links"=>[], "tags"=>["meier", "graph"], "article_id"=>374041, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.g002", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_graph_of_time_to_failure_/374041", "title"=>"Kaplan Meier graph of time to failure.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-12-13 01:07:21"}
{"files"=>["https://ndownloader.figshare.com/files/703872"], "description"=>"a<p>Likelihood ratio test, no evidence of nonlinearity. Therefore combined measure of conjunctivilisation used in logistic regression model.</p><p>BMI, body mass index.</p>", "links"=>[], "tags"=>["multivariable", "associations", "endpoint", "epilation"], "article_id"=>374218, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.t003", "stats"=>{"downloads"=>0, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Univariable_and_multivariable_associations_for_reaching_endpoint_in_the_epilation_group_/374218", "title"=>"Univariable and multivariable associations for reaching endpoint in the epilation group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-12-13 01:10:18"}
{"files"=>["https://ndownloader.figshare.com/files/703909"], "description"=>"a<p>Participants with bilateral TT had one eye randomly selected as the trial eye.</p>b<p>Unable to cooperate with visual acuity measurement.</p><p>BMI, body mass index; CF, count fingers; HM, hand movements; PL, perception of light; NPL, no perception of light; SD, standard deviation; VA, visual acuity.</p>", "links"=>[], "tags"=>["characteristics"], "article_id"=>374263, "categories"=>["Medicine", "Infectious Diseases"], "users"=>["Saul N. Rajak", "Esmael Habtamu", "Helen A. Weiss", "Amir Bedri Kello", "Teshome Gebre", "Asrat Genet", "Robin L. Bailey", "David C. W. Mabey", "Peng T. Khaw", "Clare E. Gilbert", "Paul M. Emerson", "Matthew J. Burton"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001136.t001", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_demographic_and_clinical_characteristics_of_participants_in_each_arm_of_the_trial_/374263", "title"=>"Baseline demographic and clinical characteristics of participants in each arm of the trial.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-12-13 01:11:03"}

PMC Usage Stats 178917 Jan 14:02 UTC

PMC Usage Stats | Further Information

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Relative Metric 69577004 Apr 16:00 UTC

Relative Metric

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F1000Prime20 Jan 12:05 UTC

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