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OpenTrials
Completed

NCT Number: NCT04537065

Long Term Outcome of Intravitreal Ranibizumab for ROP

premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

Medical records were collected in each group for birth history data, including gestational age (GA), birth weight (BW), and postmenstrual age (PMA) at time of intravitreal injection. The zone and stage of ROP were also recorded. All patients were evaluated for refractive errors and cycloplegic refraction was performed using a handheld auto keratorefractometer (Righton Retinomax K-plus2), and confirmed by retinoscopy examination. Refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The average corneal radius of curvature was measured by handheld auto kerato-refractometer (Righton Retinomax K-plus2). The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year
  • Three control groups with age and sex matched were included for comparison. First group included premature infants who had ROP that regressed spontaneously without intervention. Second group was corresponded to premature infants who were diagnosed to have normal retinal vasculature from the first examination after birth. The third group belonged to full term babies

Exclusion criteria

  • Premature infants who received intravitreal injection of (Ranibizumab) less than one year or had any ocular pathology

Treatment and study plan

cycloplegic refraction

Other

Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder.

The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).

Other names: Biometry

Primary outcomes

  1. cycloplegic refraction

    Time frame: 1 year after injection

    Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder

  2. biometry

    Time frame: 1 year after injection

    The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek). Examination under sedation was performed for uncooperative children.

Sponsors and collaborators

Lead sponsor

Ameera Gamal Abdelhameed

Other

Registry information

Official study title

Refractive and Biometric Outcome Following Intravitreal Injection of Ranibizumab in Retinopathy of Prematurity: Long -Term Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

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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