Refractive Error and Biometry in Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334513
• Other study ID #: 171026
• Status: Completed
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 2, 2017
• Start date: April 1, 2011
• Est. completion date: April 1, 2014

Study information

• Verified date: November 2017
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Refractive Errors
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Bevacizumab
intravitreal injection of bevacizumab
• Ranibizumab
intravitreal injection of ranibizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Ni Chen

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spherical equivalent	spherical power + half of cylinder power	at corrected age of 3 year-old
Primary	astigmatism	in cylinder power	at corrected age of 3 year-old
Secondary	axial length	axial length in mm	at corrected age of 3 year-old
Secondary	cornea radius	cornea radius in mm	at corrected age of 3 year-old
Secondary	anterior chamber depth	anterior chamber depth in mm	at corrected age of 3 year-old
Secondary	lens thickness	lens thickness in mm	at corrected age of 3 year-old