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Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa
Sponsor: AIDS Malignancy Consortium
Summary
Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV/AIDS (PLWHA). Participants include those with HIV infection and with suspected non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices and 6 clock hours of the corneal scleral limbus.
Official title: Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2023-06-21
Completion Date
2027-12-30
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Surgical
The treatment involves excision only of the conjunctival lesion with 3 mm margins. Surgeons (registered as investigators at each site) will perform the operation in accordance with the procedures outlined in the AMC-104 manual of procedures (MOP). As part of the study patients will be asked to return for follow-up evaluation 1 week, 6 weeks, 6 months, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough ocular history as well as a history of AIDS-defining illnesses and perform a slit-lamp examination of both eyes, complete with templated drawings of the conjunctiva, and careful examination of the cornea for limbal stem cell deficiency.
Locations (1)
Uganda Cancer Institute
Kampala, Uganda