trial of topical mitomycin C and interferon for ocular surface squamous neoplasia

Randomized controlled trial of topical mitomycin C and interferon for ocular surface squamous neoplasia: time to resolution
Research question:
Is mitomycin C more effective than interferon in achieving time to resolution of ocular surface squamous neoplasia for patients with ocular surface squamous neoplasia (OSSN) seeking medical treatments?
Design: Prospective, randomized, controlled, masked, single-center trial.
Hypothesis:
Primary (Time to resolution)
Null: there will be no statistical significant differences in the time to resolution of OSSN treated by mitomycin C and interferon.
Alternative: there will be a statistical significant difference in the time to resolution of OSSN treated by mitomycin C and interferon.
Secondary (Drug safety)
Null:there will be no statistical significant differences in number of adverse effects of mitomycin C and interferon.
Alternative:there will be a statistical significant difference in number of adverse effects of mitomycin C and interferon.
Primary outcome:
Time to resolution: resolution defined as the tumor resolved clinically and not detected by ultra-high resolution optical coherence tomography (UHR-OCT).
Measures: successful resolution was measured as complete resolution of the OSSN by slit-lamp examination and by ultra-high resolution optical coherence tomography (UHR-OCT).
Secondary outcome:
SafetyMeasures: count of adverse effects of mitomycin C and interferon-comparison of means between study arms
Study population: Fifty consecutive patients with clinical and UHR-OCT proven ocular surface squamous neoplasia.
Inclusion criteria:
1. Male or female.
2. Any age group.
3. Patients with non- invasive OSSN confirmed by UHR-OCT.
4. Patients seeking medical treatments.
5. If one patient did have bilateral OSSN. In this case, data from both eyes were included in the study.
6. If female childbearing age, should use a birth control measure during the study.
7. Patients willing to scheduled follow-up visits for up to 1 year.
8. Able to provide a written informed consent.
9. Willing to participate in a clinical trial.
Exclusion criteria:
1. Does not meet inclusion criteria.
2. Patient with invasive OSSN confirmed by UHR-OC.
3. Patients seeking surgical treatment.
4. Pregnant women.
5. Patients who had other significant ocular surface disease, such as severe dry eyes, ocular surface rosacea, or corneal herpes simplex disease.
6. Known allergy or sensitivity to mitomycin C or interferon.
Rational for exclusionary criteria:
Criteria 2: patients with invasive OSSN will be treated surgically.
Criteria 3: if patients request surgical treatment, we cannot use medical treatment.
Criteria 4: mitomycin C is antimetabolite medication that may causes fetal abnormalities.
Criteria 5 and 6: for safety also.
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