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CompletedNCT03334513Updated Nov 7, 2017

Refractive Error and Biometry in Retinopathy of Prematurity

An observational study in Retinopathy of Prematurity, sponsored by San Ni Chen. Completed. Open to participants aged 3 Years to 3 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by San Ni Chen · Observational

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Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
35
Ages
3 Years to 3 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Retinopathy of Prematurity

Keywords

  • Bevacizumab
  • Biometry
  • Ranibizumab
  • Refractive error
  • Retinopathy of prematurity
03

In context

Retinopathy of Prematurity

169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.

This study's enrollment of 35 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.

Browse Retinopathy of Prematurity studies →

Lead sponsor

San Ni Chen is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children with type 1 retinopathy of prematurity
  • children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)

Exclusion criteria

Exclusion Criteria:

  • children withour retinopathy of prematurity
  • children with retinopathy of prematurity received laser therapy
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • ROP group

    children with retinopathy of prematurity received either bevacizumab or ranibizumab

    Drug: Bevacizumab · Drug: Ranibizumab

Interventions

  • DrugBevacizumab

    intravitreal injection of bevacizumab

    Also known as: avastin

  • DrugRanibizumab

    intravitreal injection of ranibizumab

    Also known as: lucentis

06

What researchers measure

Primary outcomes

  1. spherical equivalent

    spherical power + half of cylinder power

    Time frame: at corrected age of 3 year-old

  2. astigmatism

    in cylinder power

    Time frame: at corrected age of 3 year-old

Secondary outcomes

  1. axial length

    axial length in mm

    Time frame: at corrected age of 3 year-old

  2. cornea radius

    cornea radius in mm

    Time frame: at corrected age of 3 year-old

  3. anterior chamber depth

    anterior chamber depth in mm

    Time frame: at corrected age of 3 year-old

  4. lens thickness

    lens thickness in mm

    Time frame: at corrected age of 3 year-old

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25462435 ↗
  • 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. PubMed 29713524 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2011 to primary completion in Apr 2014, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 7, 2017
StartActual
Apr 1, 2011
Primary completionActual
Apr 1, 2014
CompletionActual
Apr 1, 2014
Last update
Nov 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03334513
Lead sponsor
San Ni Chen
Responsible party
San Ni Chen (medical doctor, Changhua Christian Hospital) — Sponsor-investigator
First posted
Nov 7, 2017
Start date
Apr 1, 2011
Primary completion
Apr 1, 2014
Completion
Apr 1, 2014
Last update
Nov 7, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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