Conjunctival Intraepithelial Neoplasia, Corneal Intraepithelial Neoplasia
Conditions
Keywords
Conjunctival-corneal intraepithelial neoplasia, Mitomycin C, Interferon alfa 2b
Brief summary
The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.
Detailed description
The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b). Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined. Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.
Interventions
DRUGMitomycin C
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
DRUGInterferon Alfa-2b
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
Sponsors
Instituto Mexicano del Seguro Social
University of Guadalajara
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with clinical diagnosis of corneal and conjunctival intraepithelial neoplasia (CIN) with no history of ocular neoplasia
Exclusion criteria
* Patients who did not agree to participate in the study. * Patients with corneal abrasion * Patients who have the diagnosis of CIN, but are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia | One month to one year | Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects with topic therapy | One to two years | Watch as topical treatment is maintained and at least one years after the resolution of the lesion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of conjunctival-corneal intraepithelial neoplasia | One year | Watch at least one year after the resolution of the lesion to detect recurrence. |
Countries
Mexico
Outcome results
None listed