Cataract Surgery With Intracameral Triamcinolone in Infants

Cataract Clinical Trial

Official title:

The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800708
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: August 13, 2013
• Start date: January 2010

Study information

• Verified date: August 2013
• Source: Fundação Altino Ventura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.

This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 2 Years

Eligibility

Inclusion Criteria:

• Patients younger than 2 years of age

• Unilateral or bilateral congenital cataracts compromising the red reflex

Exclusion Criteria:

• Corneal opacity

• Glaucoma

• Aniridia

• Subluxated cataract

• Traumatic cataract

• Complex microphthalmia

• Persistant hyperplastic primary vitreous

• Retinal detachment

• Patients with intraoperative complications, such as IOL implanted in the sulcus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Triamcinolone acetonide

• Prednisolone syrup

Locations

Country	Name	City	State
Brazil	Altino Ventura Foundation	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Altino Ventura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual axis obscuration	Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.	1 year after surgery	No
Primary	Intraocular pressure		1 year after surgery	Yes