Adjuvant topical 5fluorouracil (5FU) for ocular surface squamous neoplasia
- 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
(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.
(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
Name Time Method 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
Name Time Method Adverse effects of using topical 5-FU 1% four times daily for one month.