Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01360151
Eligibility Criteria:
\<Polypoidal choroidal vasculopathy group\>
Inclusion Criteria:
* Male or Female patients ≥ 45yrs of age
* Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
* Signed written informed consent
* Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
* Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
* Confirmed to be active in disease activity by fluorescein angiography
* The total lesion must have the greatest linear dimension less than 5400 microns ( \~9 MPS Disc Areas ) as delineated by indocyanine green angiography
* Had not been treated in the past
* Patients willing and able to comply with all study procedures
Exclusion Criteria:
* Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
* Have known hypersensitivity to Visudyne® and Lucentis™
* Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
* History of vitrectomy
* Intraocular surgery,yttrium aluminum garnet(YAG) laser\< 1month before day 0
* Additional eye disease that could compromise visual acuity
* Ocular inflammation
* Vitreous hemorrhage
* Uncontrolled glaucoma
* Current use or of likely need for systemic medications known to be toxic to the eye.
* Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access
* Are participating in another clinical study.
* Disciform scar
* Mental illness that precludes the patient from giving informed consent
* Patients who are considered potentially unreliable
\<Control group\>
-Age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01360151
Study Brief:
Protocol Section:
NCT01360151