Triamcinolone Assisted Anterior Vitrectomy

Phase 2

Completed

• Conditions: Vitrectomy; Cataract
• Interventions: Drug: Intra ocular injection of triamcinolone acetonide

• Registration Number: NCT01051648
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2007-12
• Status Verified: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-06
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Last Update Submitted: 2010-01-15
• Study First Posted: 2010-01-18
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with vitreous in the anterior chamber whether in

  • complicated cataract surgery
  • disorganized anterior segment structures

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Exclusion Criteria

• Glaucoma patients
• Intra ocular infections
• Bacterial or fungal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triamcinolone acetenoide	Intra ocular injection of triamcinolone acetonide	Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery

Primary Outcome Measures

Name	Time	Method
Proper visualization of vitreous strands in the anterior chamber of the eye	immediately

Secondary Outcome Measures

Name	Time	Method
intraocular pressure rise	2-3 weeks

Trial Locations

Locations (2)

Kasr Al-Ainy Hospital Cairo university; 🇪🇬 Cairo, Egypt

El-Nour Eye hospital; 🇪🇬 Cairo, Egypt