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Completed

NCT Number: NCT01051648

Triamcinolone Assisted Anterior Vitrectomy

Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.

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Key information

Age range

47 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

El-Nour Eye hospital, Cairo, Egypt

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About this study

The research followed the tenets of the Declaration of Helsinki, ;informed consent were obtained from patients where all details of the procedure were explained with emphasis on the intended outcome. The research was approved by the institutional review board.

Ten eyes of 10 patients were divided into 2 groups. Group A included 6 eyes of 6 patients with accidental rupture of posterior capsule during cataract surgery (5 eyes underwent phacoemulsification technique and one underwent ECCE). Group B included four eyes of 4 patients undergoing anterior segment reconstruction (anterior vitrectomy, secondary IOL Implantation and iris repair by direct approximation using 10/0 prolene sutures). In group A the mean age was 68.1 ± 10.93 years (range 47 to 79 years), 3 were males and 3 were females. In group B the mean age was 14 ± 5.6 years (range 9 to 22 years), 3 were males and one female. Demographic data and pre-operative Information are presented in table 1 and 2.

In all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. It was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. The direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. Triamcinolone was removed as quickly & completely as possible after finishing anterior vitrectomy.

Postoperative regimen included topical steroids and antibiotics for about 4-6 weeks. Topical anti-glaucoma drugs were used in cases of high postoperative IOP for few days until stabilization of IOP. Follow up period ranged from 2 months up to 27 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with vitreous in the anterior chamber whether in
  • complicated cataract surgery
  • disorganized anterior segment structures

Exclusion criteria

  • Glaucoma patients
  • Intra ocular infections
  • Bacterial or fungal

Treatment and study plan

Intra ocular injection of triamcinolone acetonide

Drug

In all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. It was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. The direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. Triamcinolone was removed as quickly & completely as possible after finishing anterior vitrectomy

Other names: kena cort

Primary outcomes

  1. Proper visualization of vitreous strands in the anterior chamber of the eye

    Time frame: immediately

Secondary outcomes

  1. intraocular pressure rise

    Time frame: 2-3 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • AL-Nour Eye Hospital
  • Kasr El Aini Hospital

Registry information

Official study title

Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 18, 2010
Registry last updated
Jan 18, 2010

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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