Long Term Outcome of Intravitreal Ranibizumab for ROP

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Other: cycloplegic refraction

• Registration Number: NCT04537065
• Lead Sponsor: Ameera Gamal Abdelhameed

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)

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preterm infants with threshold ROP	cycloplegic refraction	-
preterm infants without ROP	cycloplegic refraction	-
preterm infants with regressed ROP	cycloplegic refraction	-
full-term infants	cycloplegic refraction	-

Primary Outcome Measures

Name	Time	Method
cycloplegic refraction	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
biometry	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.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt