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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04634604
Eligibility Criteria:
Inclusion Criteria:
* Birth weight \< 1251 grams
* Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria:
* Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or
* Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or
* Zone II, stage 2 or 3 ROP with plus disease
Exclusion Criteria:
* Previous treatment for ROP
* Stage 4 or 5 ROP in either eye
* All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant)
* Either treatment could not be done within 2 days of diagnosis of type 1 ROP
* Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment
* Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks
* Active ocular infection or purulent nasolacrimal duct obstruction in either eye
One eye will be excluded, and other eye may be eligible, if either of the following are present:
* Visually significant ocular anomaly (e.g., cataract, coloboma)
* Opacity that precludes an adequate view of the retina
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT04634604
Study Brief:
Protocol Section:
NCT04634604