Investigating Peripheral Avascular Retina in Premature Infants
Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.
This study is trying to understand how the lack of blood vessels in the eyes of premature infants with retinopathy of prematurity affects their vision as they grow up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Months to 3 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Assiut) |
| Trial ID | NCT06044181 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the long-term effects of persistent avascular retina in infants who have experienced retinopathy of prematurity (ROP). It aims to explore the natural history of peripheral nonperfusion and vascular abnormalities using advanced imaging techniques like ultrawide-field fluorescein angiography. The study will include infants with a history of ROP, both treated and untreated, to assess the structural and functional implications of these vascular anomalies. By examining these conditions, the research seeks to clarify the risks associated with persistent avascular retina and its potential impact on vision.
Who should consider this trial
Good fit: Ideal candidates include infants with persistent peripheral avascular retina who are being followed up until 18 months of age, including those with regressed ROP and those treated for threshold ROP.
Not a fit: Patients with previous laser therapy, advanced stages of ROP (stage 4 or 5), or other significant ocular pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of visual outcomes in infants with retinopathy of prematurity.
How similar studies have performed: While the study addresses a known condition, the specific focus on persistent avascular retina and its long-term implications is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with persistent peripheral avascular retina attending follow up till the age of 18 months in the core study whether; * regressed ROP: children with regressed ROP who had not received any treatment. * IVI treatment ROP: children with a history of threshold ROP treated with IVI of anti-VEGF agents. Exclusion Criteria: * Eyes with previous laser therapy. * Eyes with any other pathology, other than ROP. * Eyes with stage 4 or 5 ROP. * Patients with hypersensitivity to iodinated contrast media, liver and renal insufficiency, history of asthma. * Patients who will show hypersensitivity reaction to fluorescein angiography will be excluded from the thesis. * Patients unfit for general anesthesia.
Where this trial is running
Assiut
- Assiut University Hospital — Assiut, Egypt (Recruiting)
Study contacts
- Study coordinator: Alyaa Mohamed, MS
- Email: alyaelkabsh686@gmail.com
- Phone: 01092246445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.