Refractive and Biometric Outcome Following Intravitreal Injection of Ranibizumab in Retinopathy of Prematurity: Long -Term Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- cycloplegic refraction
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ameera Gamal Abdelhameed
Lecturer of Ophthalmology
Mansoura University