The treatment of severe forms of retinopathy of prematurity

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2015110818966N4
• Date of registration: 2015-12-21
• Prospective Registration: No
• Primary sponsor: Nicoara Simona Delia
• Public title: The treatment of severe forms of retinopathy of prematurity
• Scientific title: Laser versus avastin in the treatment of aggressive posterior retinopathy of prematurity
• Date of first enrolment: 2006-01-01
• Target sample size: 40
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/17075
• Study type: interventional
• Study design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The groups are comparable from the point of view of the data analyzed.
• Phase: N/A

Countries of recruitment

Romania

Contacts

• Name: Nicoara Simona Delia
• Affiliation: "Iuliu Hatieganu" University of Medicine and Pharmacy

• Name: Nicoara Simona Delia
• Affiliation: "Iuliu Hatieganu" University of Medicine and Pharmacy

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: aggressive posterior retinopathy of prematurity treated by laser photocoagulation or by avastin intravitreal injections.

Exclusion criteria: classic forms of retinopathy of prematurity
Exclusion criteria:

Age minimum: 1 month
Age maximum: 2 months
Gender: Both

Health Condition(s) or Problem(s) studied

Retinopathy of prematurity

Retinopathy of prematurity.
Retinopathy of prematurity

Intervention(s)

Intervention consists in 2 different methods: indirect laser photocoagulation of the retina and intravitreal injeciton of avastin. Laser treatment was performed under sedation and analgezia, all the non-vascularized retina was photocoagulated with an indirect diode laser. Bevacizumab injecitons were performed according to the following protocol: A dose of bevacizumab of 0.625 mg in 0.025 ml was injected in each eye from the study sample, according to the following protocol: The pupils were dilated with a mixture of tropicamide 0.5% and phenylephrine 0.5%. Anesthesia was achieved with 0.5% proparacaine hydrochloride administered topically, 3 times, every 2 minutes before the injection. Every eye was prepared in a sterile manner using 5% povidone iodine which was also instilled in the eye 3 minutes prior the injection. A nurse hold the infant's head during the procedure and 0.025 ml of bevacizumab (0.625 mg) were injected in pars plicata, 1.5 - 1.75 mm away from the limbus, with a 30 G needle, perpendicularly on the globe initially and then slightly directed toward the center of the eyeball. After the injection, the patients received topical tobramycin, 5 times/day, for 3 days. The patients were re-examined the next day and then every week to monitor the regression of the disease. The follow-up continued for 52 weeks, every 1 or 2 weeks until full vascularization of the retina was observed. Full vascularization was defined as follows: vascularization as far as it would develop without an active component or clinically significant tractional elements. All the treatments were carried out by the same physician and the examinations were performed by three ophthalmologists experienced in ROP..

Treatment - Other

Intervention consists in 2 different methods: indirect laser photocoagulation of the retina and intravitreal injeciton of avastin. Laser treatment was performed under sedation and analgezia, all the non-vascularized retina was photocoagulated with an indirect diode laser. Bevacizumab injecitons were performed according to the following protocol: A dose of bevacizumab of 0.625 mg in 0.025 ml was injected in each eye from the study sample, according to the following protocol: The pupils were dilated with a mixture of tropicamide 0.5% and phenylephrine 0.5%. Anesthesia was achieved with 0.5% proparacaine hydrochloride administered topically, 3 times, every 2 minutes before the injection. Every eye was prepared in a sterile manner using 5% povidone iodine which was also instilled in the eye 3 minutes prior the injection. A nurse hold the infant's head during the procedure and 0.025 ml of bevacizumab (0.625 mg) were injected in pars plicata, 1.5 - 1.75 mm away from the limbus, with a 30 G

Primary Outcome(s)

Regression of retinopathy of prematurity. Timepoint: 2 weeks after treatment. Method of measurement: Indirect ophthalmoscopy.

Secondary Outcome(s)

The condition of the retina. Timepoint: 6 months after treatment. Method of measurement: Indirect ophthalmoscopy.

Source(s) of Monetary Support

Nicoara Simona Delia

Ethics review

Status: Approved
Approval date:
Contact:

Ethic Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy