{
"info": {
"nct_id": "NCT02818816",
"official_title": "A Prospective Study to Evaluate the Effect of Preoperative Topical Brimonidine Tartrate 0.2% (Allergan, Irvine, CA) on Intraocular Pressure (IOP) of Patients Undergoing Robot-assisted Laparoscopic Prostatectomy (RALP)",
"inclusion_criteria": "* Males aged 18 years and above\n* Patients with a diagnosis of prostatic carcinoma requiring prostate surgery\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients having had an ophthalmic surgical procedure within 6 months of the beginning of the study.\n* Patients with a diagnosis of glaucoma\n* Any abnormality of the cornea which may prevent reliable applanation tonometry\n* Known allergy/ hypersensitivity reaction to Brimonidine\n* Contra-indication to Brimonidine including patients on monoamine oxidase inhibitors (MOA)\n* Patients unwilling or unable to provide informed consent\n* Patients with anticipated difficult airway management (as this may require medications and/or airway manipulations resulting in increased IOP)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Males aged 18 years and above",
"criterions": [
{
"exact_snippets": [
"Males"
],
"criterion": "gender",
"requirement_type": "specificity",
"expected_value": "male"
},
{
"exact_snippets": [
"aged 18 years and above"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18
}
]
}
}
]
},
{
"line": "* Patients with a diagnosis of prostatic carcinoma requiring prostate surgery",
"criterions": [
{
"exact_snippets": [
"diagnosis of prostatic carcinoma"
],
"criterion": "prostatic carcinoma",
"requirement_type": "diagnosis",
"expected_value": true
},
{
"exact_snippets": [
"requiring prostate surgery"
],
"criterion": "prostate surgery",
"requirement_type": "necessity",
"expected_value": true
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": [
"Must be MALE"
],
"criterion": "gender",
"requirement_type": "specificity",
"expected_value": "male"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Patients having had an ophthalmic surgical procedure within 6 months of the beginning of the study.",
"criterions": [
{
"exact_snippets": [
"ophthalmic surgical procedure"
],
"criterion": "ophthalmic surgical procedure",
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6
}
]
}
}
]
},
{
"line": "* Patients with a diagnosis of glaucoma",
"criterions": [
{
"exact_snippets": [
"diagnosis of glaucoma"
],
"criterion": "glaucoma",
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"line": "* Any abnormality of the cornea which may prevent reliable applanation tonometry",
"criterions": [
{
"exact_snippets": [
"abnormality of the cornea"
],
"criterion": "cornea",
"requirement_type": "abnormality",
"expected_value": true
}
]
},
{
"line": "* Known allergy/ hypersensitivity reaction to Brimonidine",
"criterions": [
{
"exact_snippets": [
"Known allergy/ hypersensitivity reaction to Brimonidine"
],
"criterion": "allergy",
"requirement_type": "presence",
"expected_value": "Brimonidine"
},
{
"exact_snippets": [
"Known allergy/ hypersensitivity reaction to Brimonidine"
],
"criterion": "hypersensitivity reaction",
"requirement_type": "presence",
"expected_value": "Brimonidine"
}
]
},
{
"line": "* Contra-indication to Brimonidine including patients on monoamine oxidase inhibitors (MOA)",
"criterions": [
{
"exact_snippets": [
"Contra-indication to Brimonidine"
],
"criterion": "Brimonidine",
"requirement_type": "contra-indication",
"expected_value": true
},
{
"exact_snippets": [
"patients on monoamine oxidase inhibitors (MOA)"
],
"criterion": "monoamine oxidase inhibitors (MOA)",
"requirement_type": "current medication",
"expected_value": true
}
]
},
{
"line": "* Patients unwilling or unable to provide informed consent",
"criterions": [
{
"exact_snippets": [
"unwilling or unable to provide informed consent"
],
"criterion": "informed consent",
"requirement_type": "ability to provide",
"expected_value": true
}
]
},
{
"line": "* Patients with anticipated difficult airway management (as this may require medications and/or airway manipulations resulting in increased IOP)",
"criterions": [
{
"exact_snippets": [
"anticipated difficult airway management"
],
"criterion": "airway management",
"requirement_type": "difficulty",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}