Refractive Error and Biometry in Retinopathy of Prematurity

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Drug: Bevacizumab; Drug: Ranibizumab

• Registration Number: NCT03334513
• Lead Sponsor: San Ni Chen

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

Study Timeline

• Study Start: 2011-04-01
• Primary Completion: 2014-04-01
• Study Completion: 2014-04-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROP group	Bevacizumab	children with retinopathy of prematurity received either bevacizumab or ranibizumab
ROP group	Ranibizumab	children with retinopathy of prematurity received either bevacizumab or ranibizumab

Primary Outcome Measures

Name	Time	Method
spherical equivalent	at corrected age of 3 year-old	spherical power + half of cylinder power
astigmatism	at corrected age of 3 year-old	in cylinder power

Secondary Outcome Measures

Name	Time	Method
axial length	at corrected age of 3 year-old	axial length in mm
lens thickness	at corrected age of 3 year-old	lens thickness in mm
cornea radius	at corrected age of 3 year-old	cornea radius in mm
anterior chamber depth	at corrected age of 3 year-old	anterior chamber depth in mm