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Long Term Outcome of Intravitreal Ranibizumab for ROP

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04537065
Enrollment
140
Registered
2020-09-03
Start date
2018-04-01
Completion date
2018-09-01
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Brief summary

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

Detailed 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)

Interventions

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).

Sponsors

Ameera Gamal Abdelhameed
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cycloplegic refraction1 year after injectionCycloplegic 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
biometry1 year after injectionThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026