Refractive Error and Biometry in Retinopathy of Prematurity

NCT ID: NCT03334513

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-01

Study Completion Date

2014-04-01

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

Conditions

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Retinopathy of Prematurity

Keywords

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Bevacizumab Biometry Ranibizumab Refractive error Retinopathy of prematurity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ROP group

children with retinopathy of prematurity received either bevacizumab or ranibizumab

Bevacizumab

Intervention Type DRUG

intravitreal injection of bevacizumab

Ranibizumab

Intervention Type DRUG

intravitreal injection of ranibizumab

Interventions

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Bevacizumab

intravitreal injection of bevacizumab

Intervention Type DRUG

Ranibizumab

intravitreal injection of ranibizumab

Intervention Type DRUG

Other Intervention Names

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avastin lucentis

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Ni Chen

OTHER

Sponsor Role lead

Responsible Party

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San Ni Chen

medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 25462435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29713524 (View on PubMed)

Other Identifiers

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171026

Identifier Type: -

Identifier Source: org_study_id