Triamcinolone Assisted Anterior Vitrectomy

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051648
• Other study ID #: Triam1
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: January 15, 2010
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: February 2008
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 47 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cataract
• Vitrectomy

Intervention

Drug:
• Intra ocular injection of triamcinolone acetonide
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

Locations

Country	Name	City	State
Egypt	El-Nour Eye hospital	Cairo
Egypt	Kasr Al-Ainy Hospital Cairo university	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	AL-Nour Eye Hospital, Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proper visualization of vitreous strands in the anterior chamber of the eye		immediately	Yes
Secondary	intraocular pressure rise		2-3 weeks	Yes