Trial reportThe Lancet. Global health2016
Topical fluorouracil after surgery for ocular surface squamous neoplasia in Kenya: a randomised, double-blind, placebo-controlled trial.
Trial report in The Lancet. Global health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 39 citations in OpenAlex.
- Review
- Management and outcomes of ocular surface squamous neoplasia at a tertiary hospital, South Africa.Eye (London, England) · 2025Article
- Update in the Diagnosis and Management of Ocular Surface Squamous Neoplasia (OSSN).Journal of clinical medicine · 2025Review
- Oncological principles in the management of ocular surface squamous neoplasia - A Review.Indian journal of ophthalmology · 2025Review
- Excision combined with ocular surface reconstruction followed by topical chemotherapy for ocular surface squamous neoplasia.Japanese journal of ophthalmology · 2024Article
- The Management of Ocular Surface Squamous Neoplasia (OSSN).International journal of molecular sciences · 2022Review
- Human papillomavirus-related neoplasia of the ocular adnexa.Acta ophthalmologica · 2022Article
- Article
- Treatment challenges associated with a superiorly located bulbar conjunctival mass-case report and review of the literature.American journal of ophthalmology case reports · 2022Article
- Review
- Impact of Climate Change on Eye Diseases and Associated Economical Costs.International journal of environmental research and public health · 2021Review
- Ocular surface squamous neoplasia: management and outcomes.Eye (London, England) · 2021Review
- Iatrogenic Ocular Surface Diseases Occurring during and/or after Different Treatments for Ocular Tumours.Cancers · 2021Review
- Single-Fraction Adjuvant Electronic Brachytherapy after Resection of Conjunctival Carcinoma.Cancers · 2021Article
- HIV and the eye.Community eye health · 2020Article
- Long-Term Efficacy and Safety of Subconjunctival/Perilesional 5-Fluorouracil Injections for Ocular Surface Squamous Neoplasia.Drug design, development and therapy · 2020Article
- Observational
- Extending far and wide: the role of biopsy and staging in the management of ocular surface squamous neoplasia.Clinical & experimental ophthalmology · 2019Article
- Ocular surface squamous neoplasia: angiographic characteristics and response to subconjunctival/perilesional 5-fluorouracil injections.Drug design, development and therapy · 2019Article
- Clinical Management of Ocular Surface Squamous Neoplasia: A Review of the Current Evidence.Ophthalmology and therapy · 2018Review
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
13 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundOcular surface squamous neoplasia (OSSN) is an aggressive eye tumour particularly affecting people with HIV in Africa. Primary treatment is surgical excision; however, tumour recurrence is common. We assessed the effect of fluorouracil 1% eye drops after surgery on recurrence.
methodsWe did this multicentre, randomised, placebo-controlled trial in four centres in Kenya. We enrolled patients with histologically proven OSSN aged at least 18 years. After standard surgical excision, participants were randomly allocated to receive either topical fluorouracil 1% or placebo four times a day for 4 weeks. Randomisation was stratified by surgeon, and participants and trial personnel were masked to assignment. Patients were followed up at 1 month, 3 months, 6 months, and 12 months. The primary outcome was clinical recurrence (supported by histological assessment where available) by 1 year, and analysed by intention to treat. The sample size was recalculated because events were more common than anticipated, and trial enrolment was stopped early. The trial was registered with Pan-African Clinical Trials Registry (PACTR201207000396219).
findingsBetween August, 2012, and July, 2014, we assigned 49 participants to fluorouracil and 49 to placebo. Four participants were lost to follow-up. Recurrences occurred in five (11%) of 47 patients in the fluorouracil group and 17 (36%) of 47 in the placebo group (odds ratio 0·21, 95% CI 0·07-0·63; p=0·01). Adjusting for passive smoking and antiretroviral therapy had little effect (odds ratio 0·23; 95% CI 0·07-0·75; p=0·02). Adverse effects occurred more commonly in the fluorouracil group, although they were transient and mild. Ocular discomfort occurred in 43 of 49 patients in the fluorouracil group versus 36 of 49 in the placebo group, epiphora occurred in 24 versus five, and eyelid skin inflammation occurred in seven versus none.
interpretationTopical fluorouracil after surgery substantially reduced recurrence of OSSN, was well-tolerated, and its use recommended.
fundingBritish Council for Prevention of Blindness and the Wellcome Trust.
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