Conjunctival Neoplasms
Conditions
Interventions
This is a non-randomized, controlled, interventional clinical study with a parallel two-arm design. A total of 16 participants with ocular surface tumors will be included and allocated in an alternati
Sponsors
Banco de Olhos de Sorocaba
Universidade Federal de São Paulo (UNIFESP)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both genders; age 18 years or older; presence of one of the following ocular surface tumors: conjunctival nevus, conjunctival melanoma, ocular surface squamous neoplasia, or primary acquired melanosis of the conjunctiva; best corrected visual acuity better than 20/40 in the contralateral eye; provision of written informed consent
Exclusion criteria
Exclusion criteria: Presence of corneal disease in the affected eye, including previous opacities, scars, dystrophies, or infections; systemic diseases with ocular involvement; pregnancy; previous ocular surface surgery in the affected eye; allergy to any medication used in the postoperative period; glaucoma or ocular hypertension, eyelid disease, or lacrimal disease in the affected eye; any ophthalmologic condition or disease in the contralateral eye other than low refractive error; presence of a small lesion allowing primary conjunctival closure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the polydioxanone membrane in conjunctival reconstruction. Assessed by clinical examination using slit-lamp biomicroscopy. Parameters to be observed include complete epithelialization rate, degree of inflammation, fibrosis, and graft integration during a 90-day follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate time to complete epithelialization. Assessed by clinical examination. It will be measured in days until full epithelial coverage of the ocular surface.;To evaluate postoperative inflammation. Assessed by slit-lamp biomicroscopy. It will be graded according to clinical inflammatory signs during follow-up.;To evaluate postoperative complications. Assessed by clinical examination. It will be recorded as the presence or absence of complications such as infection, symblepharon, or graft displacement.;To evaluate visual acuity. Assessed using standardized visual acuity testing. It will be measured using the Snellen scale during follow-up. | — |
Countries
BR
Contacts
Public ContactDaniel Diniz da Gama
Universidade Federal de São Paulo (UNIFESP)
Outcome results
None listed