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Completed

NCT Number: NCT01800708

Cataract Surgery With Intracameral Triamcinolone in Infants

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

6 week–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altino Ventura Foundation

Recife, Pernambuco, 50070020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone Acetonide

Drug

Other names: Triancinolona Ophthalmos

Prednisolone syrup

Drug

Primary outcomes

  1. Visual axis obscuration

    Time frame: 1 year after surgery

    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.

  2. Intraocular pressure

    Time frame: 1 year after surgery

Sponsors and collaborators

Lead sponsor

Fundação Altino Ventura

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Feb 28, 2013
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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