Retinopathy of Prematurity - Visual Function and Retinal Structure

Официальное название

Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure

Обзор

Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common. In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).

Подробное описание

Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.

In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).

The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.

Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.

Первичные конечные точки

• Width of the foveal avascular zone [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years]
• Choroidal vascularity [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.]
• Retinal nerve fiber layer thickness [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.]
• Length of persistent avascular retina [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.]
• Width of the visual field [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.]

Вторичные конечные точки (2)

• Correlation between cerebral visual impairment and brain hemorrhages [Срок оценки: Neonatal period to time for data collection in the current study]
• Visual acuity [Срок оценки: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.]

Критерии участия

Критерии включения

• Patients treated for ROP with either laser or injection of A-VEGF.
• Patients previously diagnosed with ROP but not treated for the condition.

Критерии исключения

• Age below six years at date of examination.
• A developmental level not compatible with performing the study examinations.
• Patients born or treated outside Norway
• Known ocular or systemic disease that can give structural or functional changes in the retina.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Публикации

• Hamad AE, Moinuddin O, Blair MP, Schechet SA, Shapiro MJ, Quiram PA, Mammo DA, Berrocal AM, Prakhunhungsit S, Cernichiaro-Espinosa LA, Mukai S, Yonekawa Y, Ung C, Holz ER, Harper CA 3rd, Young RC, Besirli CG, Nagiel A, Lee TC, Gupta MP, Walsh MK, Khawly JA, Campbell JP, Kychenthal A, Nudleman ED, Robinson JE, Hartnett ME, Calvo CM, Chang EY. Late-Onset Retinal Findings and Complications in Untreat PMID 32059986
• Lai TT, Yang CM, Hsieh YT, Yeh PT, Huang CW, Tsai CY. RATE OF AND TIME TO COMPLETE RETINAL VASCULARIZATION IN PREMATURE INFANTS AND ASSOCIATED FACTORS. Retina. 2023 Jan 1;43(1):102-110. doi: 10.1097/IAE.0000000000003627. PMID 36201755
• Sternfeld A, Rahmani S, Rossen JL, Zhang DL, Li YD, Quan VL, Huang R, Yoon HH. Long-term retinal vasculature abnormalities following intravitreal bevacizumab for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2022 Jun;260(6):1915-1921. doi: 10.1007/s00417-021-05499-0. Epub 2021 Dec 1. PMID 34851464
• Ling XC, Kang EY, Huang JL, Chou HD, Liu L, Lai CC, Chen KJ, Hwang YS, Wu WC. Persistent Vascular Anomalies in Retinopathy of Prematurity Children: Ultrawide-field Fluorescein Angiography Findings until School Age. Ophthalmol Sci. 2023 Feb 7;3(3):100281. doi: 10.1016/j.xops.2023.100281. eCollection 2023 Sep. PMID 37113473
• Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5. PMID 17065917
• Obata S, Matsumoto R, Iwasa M, Kakinoki M, Sawada O, Sawada T, Saishin Y, Ohji M. Visual field after anti-vascular endothelial growth factor therapy and laser treatment for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3207-3213. doi: 10.1007/s00417-023-06227-6. Epub 2023 Sep 6. PMID 37674073
• McLoone E, O'Keefe M, McLoone S, Lanigan B. Effect of diode laser retinal ablative therapy for threshold retinopathy of prematurity on the visual field: results of goldmann perimetry at a mean age of 11 years. J Pediatr Ophthalmol Strabismus. 2007 May-Jun;44(3):170-3. doi: 10.3928/0191-3913-20070301-10. PMID 17542439
• Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity: results of Goldmann perimetry at the age of 10 years. Arch Ophthalmol. 2001 Aug;119(8):1120-5. doi: 10.1001/archopht.119.8.1120. PMID 11483077

Идентификаторы

NCT: NCT07427719 · 927328

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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