Ocular Surface Squamous Neoplasia: Risk factors, diagnosis, management and outcomes at a Tertiary Eye Hospital in South Africa
- Conditions
- CancerEye Diseases
- Registration Number
- PACTR201912900667480
- Lead Sponsor
- St John Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients presenting with symptomatic conjunctival masses that have:
1.Suspicious features of OSSN on clinical examination
a.Leukoplakia
b.Feeder vessels
c.Pigmentation
2.Persistent symptoms despite topical medical therapy
a.Redness
b.Foreign body sensation
c.Blurred vision
1.Age less than 18 years
2.Pregnant or breastfeeding
3.Previous surgery or topical chemotherapy in the presenting eye
4.Masses with invasion of adjacent structures: forniceal conjunctiva, palpebral conjunctiva, tarsal conjunctiva, lacrimal punctum and canaliculi, plica, caruncle, anterior or posterior eyelid lamellae, eyelid margin, and/or intraocular compartments.
5.Neurological conditions that prevent performing study investigations (AS-OCT, IC, methylene blue stain)
6.Heritable conditions that predispose to conjunctival tumours (Xeroderma pigmentosum and oculocutaneous albinism)
7.The presence of primary acquired melanosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare non-invasive diagnostic methods (cytology, AS-OCT, methylene blue staining) with histology (gold standard) in the diagnosis with OSSN <br>To evaluate the outcomes (success and recurrence rates) with OSSN treatment (medical and surgical) over a 1-year period<br>
- Secondary Outcome Measures
Name Time Method To identify the characteristics associated with successful OSSN treatment and with OSSN recurrence over a 1-year period<br>To describe the adverse events associated with surgical and medical treatment of OSSN<br>