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Completed

NCT Number: NCT03334513

Refractive Error and Biometry in Retinopathy of Prematurity

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Refractive Errors Retinal Diseases

Age range

3 year–3 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

intravitreal injection of bevacizumab

Other names: avastin

ranibizumab

Drug

intravitreal injection of ranibizumab

Other names: lucentis

Primary outcomes

  1. spherical equivalent

    Time frame: at corrected age of 3 year-old

    spherical power + half of cylinder power

  2. astigmatism

    Time frame: at corrected age of 3 year-old

    in cylinder power

Secondary outcomes

  1. axial length

    Time frame: at corrected age of 3 year-old

    axial length in mm

  2. cornea radius

    Time frame: at corrected age of 3 year-old

    cornea radius in mm

  3. anterior chamber depth

    Time frame: at corrected age of 3 year-old

    anterior chamber depth in mm

  4. lens thickness

    Time frame: at corrected age of 3 year-old

    lens thickness in mm

Sponsors and collaborators

Lead sponsor

San Ni Chen

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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