Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Rajak SN
PROVIDER: S-EPMC3236738 | biostudies-literature | 2011 Dec
REPOSITORIES: biostudies-literature
Publications
Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial.
Rajak Saul N SN Habtamu Esmael E Weiss Helen A HA Kello Amir Bedri AB Gebre Teshome T Genet Asrat A Bailey Robin L RL Mabey David C W DC Khaw Peng T PT Gilbert Clare E CE Emerson Paul M PM Burton Matthew J MJ
PLoS medicine 20111213 12
<h4>Background</h4>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.<h4>Methods and findings</h4 ...[more]
Similar Datasets
Project description:Trachoma causes blindness through an anatomical abnormality called trichiasis (lashes touching the eye). Trichiasis can recur after corrective surgery. We tested the hypothesis that using absorbable sutures instead of silk sutures might reduce the risk of recurrent disease among patients with major trichiasis in a randomised trial.1,300 individuals with major trichiasis from rural villages in the Amhara Region of Ethiopia were recruited and assigned (1:1) by computer-generated randomisation sequence to receive trichiasis surgery using either an absorbable suture (polyglactin-910) or silk sutures (removed at 7-10 days) in an otherwise identical surgical technique. Participants were examined every 6 months for 2 years by clinicians masked to allocation. The primary outcome measure was recurrent trichiasis (?one lash touching the eye) at 1 year. There was no difference in prevalence of recurrent trichiasis at 1 year (114 [18.2%] in the absorbable suture group versus 120 [19.7%] in the silk suture group; odds ratio?=?0.90, 95% CI 0.68-1.20). The two groups also did not differ in terms of corneal opacification, visual acuity, conjunctival inflammation, and surgical complications.There was no evidence that use of absorbable polyglactin-910 sutures was associated with a lower prevalence of trichiasis recurrence at 1 year postsurgery than silk sutures. However, from a programmatic perspective, polyglactin-910 offers the major advantage that patients do not have to be seen soon after surgery for suture removal. The postoperative review after surgery using absorbable polyglactin-910 sutures can be delayed for 3-6 months, which might allow us to better determine whether a patient needs additional surgery.ClinicalTrials.gov NCT00522860.
| S-EPMC3236737 | biostudies-literature
Project description:BackgroundWe re-examined the participants of a clinical trial four years after enrolment to identify which of the two most commonly used eyelid surgery procedures to treat the blinding stage of trachoma (trachomatous trichiasis, TT), the posterior Lamellar Tarsal Rotation (PLTR) and Billamelar Tarsal Rotation (BLTR), gives better results in the long-term.MethodsA randomised, controlled, single masked clinical trial was done in Ethiopia. At baseline, adults (aged >18 years with upper lid unoperated TT were recruited from a community-based screening. Participants were randomly assigned (1:1), to either BLTR or PLTR surgery, stratified by surgeon. At 4 years an independent assessor masked to allocation examined the trial participants' eyes using the same procedures as for the baseline and earlier follow-ups. The primary outcome was the proportion of individuals who had recurrence (postoperative TT, PTT) at the 4-year examination, or a history of repeat surgery in the 4-year period. The intervention effect was estimated by logistic regression, controlled for surgeon as a fixed effect in the model. The trial is registered with the Pan African Clinical Trials Registry (number PACTR201401000743135).Findings1000 participants with TT were enrolled, randomly assigned, and treated (501 in the BLTR group and 499 in the PLTR group) between Feb 13, 2014, and May 31, 2014. At year 4, 943 (94.3%) participants were re-examined (471, PLTR; 472, BLTR) and included in the primary outcome analysis. PTT had developed in 169/943 (17•9%) study eyes, among which 129 (76•3%) had minor trichiasis (≤5 lashes touching the eye). PTT was significantly more frequent at 4-year in the BLTR arm (105/472 [22•2%]) than the PLTR arm (64/471 [13•6%]), adjusted OR 1•82 (95% CI, 1•29-2•56); p = 0•0006, with 8•6% (95%CI 3•8-13•5) risk difference.InterpretationThe PLTR surgical procedure had superior long-term outcomes to the BLTR with significantly lower risk of PTT supporting the current WHO guideline that the PLTR should be the procedure of choice for training new surgeons in the programmatic management of TT.
| S-EPMC6933225 | biostudies-literature
Project description:IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.
| S-EPMC7202705 | biostudies-literature
Project description:BackgroundWHO endorsed the use of epilation as an alternative treatment to surgery for the management of both minor unoperated TT (UTT) and postoperative TT (PTT). However, some trachoma control programmes hesitated to implement epilation citing concerns that it would hamper TT surgical acceptance and result in larger numbers of and stiffer trichiatic eyelashes than the original TT lashes. We investigated the burden and phenotypes of post-epilation trichiatic eyelashes, and willingness to accept surgical management separately in unoperated and postoperative TT cases.Methodology/principal findingsWe recruited cases with minor (≤5 eyelashes from the upper eyelid touching the eye or evidence of epilation in <1/3rd of the upper eyelid) UTT (170) and PTT (169) from community-based screenings in Amhara Region, Ethiopia. Participants eyes were examined and data on present and future willingness to accept surgical management collected at baseline and every month for 6-months. Eyelashes touching the eye were counted and their phenotypes documented. Participants were trained on how to epilate. Epilation was done by the participants at home and by the examiner during follow-ups when requested by the participant. Follow-up rates were ≥97%. There was evidence of a significant reduction in the burden of trichiatic eyelashes in unoperated (mean difference = -0.90 [-1.11- -0.69]; RR = 0.50 [95% CI, 0.40-0.62]; p<0.0001), and postoperative (mean difference = -1.16 [-1.36- -0.95]; RR = 0.38 [95% CI, 0.31-0.48]; p<0.0001) cases 6-month after frequent epilation. Post-epilation trichiatic eyelashes at 6-months had higher odds of being thin (40.2% vs 55.8%, OR = 1.88 [95% CI, 1.21-2.93]; p = 0.0048), weak (39.8% vs 70.8%, OR = 3.68 [95%CI,2.30-5.88]; p<0.0001), and half-length (30.9% vs 43.3%, OR = 1.71 [1.09-2.68]; p = 0.020) than the pre-epilation trichiatic eyelashes in unoperated cases. There was a significant increase in the proportion of weak trichiatic eyelashes (OR = 1.99 [95% CI, 1.03-3.83; p = 0.039) in postoperative cases. In all 6 follow-up time points, 120/164 (73.2%) of unoperated and 134/163 (82.2%) of postoperative cases indicated that they would accept surgery if their trichiasis progressed.Conclusions/significanceIn this study setting, frequent epilation neither hampers surgical acceptance nor results in more damaging trichiatic eyelashes than the pre-epilation lashes; and can be used as an alternative to the programmatic management of minor unoperated and postoperative TT cases.
| S-EPMC7769600 | biostudies-literature
Project description:PurposeEight million people have trachomatous trichiasis (TT). The World Health Organization (WHO) recommends entropion surgery for TT regardless of severity. However, epilation is widely practiced for treating minor TT (1-5 lashes touching the globe). We report the frequency and effectiveness of patient-initiated epilation and its relationship to corneal opacity.DesignCross-sectional baseline data of individuals recruited to 2 randomized, clinical trials.ParticipantsWe included 2556 individuals (4310 eyes) with previously unoperated TT in ≥ 1 eye.MethodsA single ophthalmologist examined all participants for signs of trachoma using WHO grading systems with additional assessment of entropion grading, location and number of trichiatic lashes, and evidence of epilation. A questionnaire enquired about epilation practices.Main outcome measuresThe association between epilation and degree of corneal opacity. Epilation practices of TT patients.ResultsCentral corneal scarring was present in 1436 (33%) eyes. Entropion was absent/mild in 2328 (54%) eyes, moderate in 1259 (29.2%), and severe in 723 (16.8%). The median number of lashes touching the eye was 2 (interquartile range, 1-5; range, 0-133). There was clinical evidence of epilation in 3018 (70%) eyes, of which 738 (24%) were successfully epilated (no lashes touching globe). Epilation was performed frequently (at least monthly in 3311 [76.8%] eyes), by someone other than the patient (92.8%), and using locally made forceps (88.9%). Controlling for age and degree of entropion, successful epilation was associated with less corneal opacity (odds ratio [OR], 0.61; 95% confidence interval [CI]. 0.43-0.88; P = 0.007). The association was only significant in patients with severe entropion (OR, 0.07; 95% CI, 0.02-0.25; P<0.005).ConclusionsWe found an association between successful epilation and less central corneal opacity. This indicates the importance of preventing eyelashes from touching the cornea, particularly in individuals with severe entropion. This is a cross-sectional study; therefore, a causative relationship cannot be concluded. However, the results suggest that among patients who decline or are unable to access surgery, and perhaps in minor TT where the management remains controversial, the provision of high-quality forceps and epilation training may be beneficial.Financial disclosure(s)The authors have no proprietary or commercial interest in any of the materials discussed in this article.
| S-EPMC3694301 | biostudies-literature
Project description:BackgroundStress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.ObjectiveTo compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.Design, setting, and participantsA noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries.InterventionParticipants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group.Outcome measurements and statistical analysisThe primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery.Results and limitationsA total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} -11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS.ConclusionsUsing a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS.Patient summaryUrinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.
| S-EPMC8175331 | biostudies-literature
Project description:To determine the effect of trichiasis surgery on visual acuity.A total of 439 participants in the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) trial had visual and subjective concerns measured before and 6 months after surgery. Trichiasis surgery was performed in at least 1 eye by integrated eye care workers. Visual acuity was measured using illiterate E versions of Early Treatment Diabetic Retinopathy Study charts with standardized, forced-choice procedures. Improvement was defined as improvement in visual acuity greater than 1 line (5 letters).The mean improvement in visual acuity for the eyes that had surgery was 0.129 logMAR units (P < .001). Surgery was associated with improvement in visual acuity compared with no surgery (odds ratio, 1.68; 95% confidence interval, 1.04-2.70). Independent predictors of visual acuity improvement in the eyes that had surgery included the number of lashes touching the globe prior to surgery and baseline visual acuity. Among patients, 93.8% described significant pain and 90.4% significant photophobia at baseline compared with only 1.4% and 0.9%, respectively, following surgery.Surgery to correct trichiasis appears to provide significant visual acuity improvement as well as a decrease in subjective concerns in patients with trachomatous trichiasis.clinicaltrials.gov Identifier: NCT00347776.
| S-EPMC4700533 | biostudies-literature
Project description:PurposeTo report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).DesignMulticenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).ParticipantsSeven hundred eighty-five patients with age-related cataract.MethodsThis trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.Main outcome measuresWe enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.ConclusionsFemtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.
| S-EPMC7397499 | biostudies-literature
Project description:BackgroundOver 1.2 million people are blind from trachomatous trichiasis (TT). Lid rotation surgery is the mainstay of treatment, but recurrence rates can be high. We investigated the outcomes (recurrence rates and other complications) of posterior lamellar tarsal rotation (PLTR) surgery, one of the two most widely practised TT procedures in endemic settings.Methodology/principal findingsWe conducted a two-year follow-up study of 1300 participants who had PLTR surgery, conducted by one of five TT nurse surgeons. None had previously undergone TT surgery. All participants received a detailed trachoma eye examination at baseline and 6, 12, 18 and 24 months post-operatively. The study investigated the recurrence rates, other complications and factors associated with recurrence. Recurrence occurred in 207/635 (32.6%) and 108/641 (16.9%) of participants with pre-operative major (>5 trichiatic lashes) and minor (<5 lashes) TT respectively. Of the 315 recurrences, 42/315 (3.3% overall) had >5 lashes (major recurrence). Recurrence was greatest in the first six months after surgery: 172 cases (55%) occurring in this period. Recurrence was associated with major TT pre-operatively (OR 2.39, 95% CI 1.83-3.11), pre-operative entropic lashes compared to misdirected/metaplastic lashes (OR 1.99, 95% CI 1.23-3.20), age over 40 years (OR 1.59, 95% CI 1.14-2.20) and specific surgeons (surgeon recurrence risk range: 18%-53%). Granuloma occurred in 69 (5.7%) and notching in 156 (13.0%).Conclusions/significanceRisk of recurrence is high despite high volume, highly trained surgeons. However, the vast majority are minor recurrences, which may not have significant corneal or visual consequences. Inter-surgeon variation in recurrence is concerning; surgical technique, training and immediate post-operative lid position require further investigation.
| S-EPMC3749971 | biostudies-literature
Project description:BackgroundTrachomatous trichiasis is the leading infectious cause of blindness worldwide. The World Health Organization recommends eyelid surgery to reduce the risk of visual impairment from trichiasis. Unfortunately, the number of cases operated has grown less than expected. An understanding of barriers is fundamental for instituting measures to increase surgical uptake. Therefore, the aim of this study was to explore barriers of TT surgery implementation.MethodsA qualitative study design was employed in December 2019. Purposive sampling technique was used to select three districts from Gamo zone, Southern Ethiopia. We conducted 9 FGDs and 12 in-depth interviews. Data was collected by audio tape recorder in Amharic and Gamogna languages and then transcribed to English language. The recorded interviews and focus group discussions were transcribed to verbatim (written text) and thematic analysis was done manually and reported accordingly.Findingswe explored a number of barriers that hindered implementation of trichiasis surgery. The recurrence of trichiasis after surgery was the main challenges faced by operated individuals. The other barriers reported are negative perception towards trichiasis surgery, lack of logistic and supplies, transportation access problem for remote communities, inadequate trained health professional, less commitment from higher officials, lack of interest of integrated eye care workers due to incentive issues, believes of patients waiting supernatural power for healing service and carelessness of patients to undertake operation.Conclusion and recommendationPost-surgical trichiasis, lack of commitment from government officials and negative perception of patients towards the disease were considered as the reported barriers for implementation of trachomatous trichiasis. Closely supervising the integrated eye care workers would be the first task for district health offices to increase the uptake and improve the quality of service. Logistics and supplies should be made available and adequate to address all affected people in the community.
| S-EPMC8476041 | biostudies-literature