Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Room E 03.136, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.
Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Ophthalmol. 2019 Nov 9;19(1):220. doi: 10.1186/s12886-019-1225-8.
Children with a brain tumor have a high risk of impaired vision. Up to now, visual acuity measurement, visual field testing and orthoptic testing are the most informative diagnostic investigations for the assessment of visual function. Evaluating vision in children can be challenging given the challenges in cooperation, concentration and age-dependent shifts in visual tests. Since visual loss due to a brain tumor can be progressive and irreversible, we must aim to detect visual impairment as early as possible. Several studies have shown that optical coherence tomography facilitates discovery of nerve fiber damage caused by optic nerve glioma. Consequently, early detection of potential ocular damage will effect treatment decisions and will provide timely referral to visual rehabilitation centers.
METHODS/DESIGN: The CCISS study is a prospective, observational, multicenter cohort study in The Netherlands. Patients aged 0-18 years with a newly diagnosed brain tumor are invited for inclusion in this study. Follow-up visits are planned at 6, 12, 18 and 24 months. Primary endpoints are visual acuity, visual field and optical coherence tomography parameters (retinal nerve fiber layer thickness and ganglion cell layer - inner plexiform layer thickness). Secondary endpoints include the course of visual function (measured by visual acuity, visual field and optical coherence tomography at different follow-up visits), course of the disease and types of treatment.
The CCISS study will heighten the awareness of visual impairment in different types of brain tumors in children. This study will show whether optical coherence tomography leads to earlier detection of visual impairment compared to standard ophthalmological testing (i.e. visual acuity, visual field testing) in children with a brain tumor. Furthermore, the systematic approach of ophthalmological follow-up in this study will give us insight in the longitudinal relation between the course of visual function, course of the disease and types of treatment in children with a brain tumor.
The CCISS study is prospectively registered in the Netherlands Trial Register (NTR) since April 2019. Identifier: NL7697.
患有脑瘤的儿童视力受损的风险很高。到目前为止，视力测量、视野测试和斜视测试是评估视觉功能最具信息量的诊断检查。由于儿童合作、注意力集中和视觉测试因年龄而异的挑战，评估儿童的视力具有挑战性。由于脑瘤引起的视力丧失可能是进行性和不可逆转的，我们必须尽早发现视力障碍。几项研究表明，光学相干断层扫描有助于发现视神经胶质瘤引起的神经纤维损伤。因此，早期发现潜在的眼部损伤将影响治疗决策，并及时转介至视觉康复中心。
方法/设计：CCISS 研究是荷兰的一项前瞻性、观察性、多中心队列研究。邀请新诊断为脑瘤的 0-18 岁患者参加本研究。计划在 6、12、18 和 24 个月进行随访。主要终点是视力、视野和光学相干断层扫描参数（视网膜神经纤维层厚度和节细胞层-内丛状层厚度）。次要终点包括视觉功能的病程（通过不同随访时的视力、视野和光学相干断层扫描测量）、疾病的病程和治疗类型。
CCISS 研究将提高对儿童不同类型脑瘤视力障碍的认识。本研究将表明，与标准眼科检查（即视力、视野测试）相比，光学相干断层扫描是否能更早地发现脑瘤儿童的视力障碍。此外，本研究中眼科随访的系统方法将使我们深入了解脑瘤儿童视觉功能的病程、疾病的病程和治疗类型之间的纵向关系。
CCISS 研究自 2019 年 4 月起在荷兰试验注册处（NTR）前瞻性注册。标识符：NL7697。
