Triamcinolone Assisted Anterior Vitrectomy

Cataract Clinical Trial

Official title: Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Vitrectomy

• NCT number: NCT01051648
• Study type: Interventional
• Source: Cairo University
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Completion date: June 2008