Long Term Outcome of Intravitreal Ranibizumab for ROP

A

Ameera Gamal Abdelhameed

Status

Completed

Conditions

Retinopathy of Prematurity

Treatments

Other: cycloplegic refraction

Study type

Observational

Funder types

Other

Identifiers

NCT04537065
Intravitreal Ranibizumab

Details and patient eligibility

About

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

Full description

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)

Enrollment

140 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 4 patient groups

preterm infants without ROP
Treatment:
Other: cycloplegic refraction
preterm infants with regressed ROP
Treatment:
Other: cycloplegic refraction
preterm infants with threshold ROP
Treatment:
Other: cycloplegic refraction
full-term infants
Treatment:
Other: cycloplegic refraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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