Clinical trial NCT03334513: Refractive Error and Biometry in Retinopathy of Prematurity
Official title: Refractive and Biometric Outcomes in Patients With Retinopathy of Prematurity Treated With Intravitreal Injection of Ranibizumab as Compared With Bevacizumab - a Clinical Study of Correction at Three Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: Bevacizumab
Biometry
Ranibizumab
Refractive error
Retinopathy of prematurity
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment

Brief summary: The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.

Detailed description: Purpose:

To compare refractive and biometric outcomes in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus bevacizumab (IVB), at a corrected age of 3 years.

Methods:

A retrospective case series compared cycloplegic refractive statuses and biometric statuses in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.

Comparison of refractive errors and biometric findings between the two groups was performmed and multivariate analysis of possible factors contributive to visual acuity was also performmed

Eligibility criteria: Inclusion Criteria:

* children with type 1 retinopathy of prematurity
* children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)

Exclusion Criteria:

* children withour retinopathy of prematurity
* children with retinopathy of prematurity received laser therapy

Primary outcomes:
measure: spherical equivalent
timeFrame: at corrected age of 3 year-old
measure: astigmatism
timeFrame: at corrected age of 3 year-old
Secondary outcomes:
measure: axial length
timeFrame: at corrected age of 3 year-old
measure: cornea radius
timeFrame: at corrected age of 3 year-old
measure: anterior chamber depth
timeFrame: at corrected age of 3 year-old
measure: lens thickness
timeFrame: at corrected age of 3 year-old
Other outcomes:
Locations:
Study officials:
References:
citation: Chen SN, Lian I, Hwang YC, Chen YH, Chang YC, Lee KH, Chuang CC, Wu WC. Intravitreal anti-vascular endothelial growth factor treatment for retinopathy of prematurity: comparison between Ranibizumab and Bevacizumab. Retina. 2015 Apr;35(4):667-74. doi: 10.1097/IAE.0000000000000380.
citation: Chen YC, Chen SN, Yang BC, Lee KH, Chuang CC, Cheng CY. Refractive and Biometric Outcomes in Patients with Retinopathy of Prematurity Treated with Intravitreal Injection of Ranibizumab as Compared with Bevacizumab: A Clinical Study of Correction at Three Years of Age. J Ophthalmol. 2018 Mar 11;2018:4565216. doi: 10.1155/2018/4565216. eCollection 2018.