Refractive Error and Biometry in Retinopathy of Prematurity

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ROP group<br>children with retinopathy of prematurity received either bevacizumab or ranibizumab | Drug: Bevacizumab<br>* intravitreal injection of bevacizumab<br>* Other names: avastin;Drug: Ranibizumab<br>* intravitreal injection of ranibizumab<br>* Other names: lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spherical equivalent | spherical power + half of cylinder power | at corrected age of 3 year-old | 
| astigmatism | in cylinder power | at corrected age of 3 year-old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length | axial length in mm | at corrected age of 3 year-old | 
| cornea radius | cornea radius in mm | at corrected age of 3 year-old | 
| anterior chamber depth | anterior chamber depth in mm | at corrected age of 3 year-old | 
| lens thickness | lens thickness in mm | at corrected age of 3 year-old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bevacizumab, Biometry, Ranibizumab, Refractive error, Retinopathy of prematurity