Pediatric Cataract Surgery Outcomes Registry
Please note: The endnotes and cross references are found in the C02 protocol attachment
The protocol involves the establishment of a registry to collect data on children who have undergone cataract surgery. Children and teens who have already had surgery in at least one eye within the last 45 days for cataract will be invited to participate. If interested, written informed consent will be obtained from the parent or guardian and a child assent form (if applicable) will be signed by the patient.
Informed consent, screening for eligibility, and enrollment into the registry occurs after cataract surgery has been performed (in at least one eye if bilateral). The surgical procedure is not part of the protocol. Additionally, there is no protocol regarding post-op or subsequent patient management. The data collected into the registry database are available in each participating clinic[Single Quote]s medical record or from interview with parent after consent. Information may be collected on a later fellow eye cataract surgery for subjects previously enrolled.
A central web-based electronic database will capture clinical data that is collected as part of usual care. Cataract surgery, additional clinical testing, and follow-up visits will be performed according to the clinical center[Single Quote]s usual routine. No procedures will be performed specifically for the study except that participating sites will be asked to perform a visual acuity measurement using the amblyopia treatment study protocol before the last annual data collection.
Children who have had cataract surgery(ies) within the last 45 days for one or both eyes will be eligible for the registry if they meet the following criteria:
1. Less than 13 years of age at time of surgery (if had bilateral surgeries at the time of enrollment, less than 13 years of age at time of surgery in at least one eye)
2. Subjects with traumatic cataracts are eligible
3. Subjects with ocular comorbidities such as a persistent hyperplastic primary vitreous (PHPV, a.k.a. persistent fetal vasculature), retinopathy of prematurity, or Peter[Single Quote]s anomaly are eligible.