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Adjuvant topical 5fluorouracil (5FU) for ocular surface squamous neoplasia

Not Applicable
Conditions
Ocular surface squamous neoplasia
Registration Number
PACTR201207000396219
Lead Sponsor
ondon School of Hygiene & Tropical Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
504
Inclusion Criteria

(i)Histologically proven ocular surface squamous neoplasia (OSSN)
(ii) attended for post-operative follow-up within the first two months of excision
(iii)Healed excision site.
(iv)At least 18 years of age.

Exclusion Criteria

(i)Prior treatment with topical or subconjunctival antimetabolite drugs such as 5FU, Mitomycin C (MMC) to the same eye or systemic cytotoxic drugs.
(ii)Patients who may need more radical surgery than a simple excision eg. features suggestive of metastasis.
(iii)Pregnant or breastfeeding mothers.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Development of a clinical recurrence of the lesion at any time during the first year of follow-up, confirmed by histology where this was available
Secondary Outcome Measures
NameTimeMethod
Adverse effects of using topical 5-FU 1% four times daily for one month.
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