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Clinical Trials/NCT01051648
NCT01051648
Completed
Phase 2

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

Cairo University2 sites in 1 country10 target enrollmentDecember 2007

Overview

Phase
Phase 2
Intervention
Intra ocular injection of triamcinolone acetonide
Conditions
Vitrectomy
Sponsor
Cairo University
Enrollment
10
Locations
2
Primary Endpoint
Proper visualization of vitreous strands in the anterior chamber of the eye
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
June 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

Triamcinolone acetenoide

Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery

Intervention: Intra ocular injection of triamcinolone acetonide

Outcomes

Primary Outcomes

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

Time Frame: immediately

Secondary Outcomes

  • intraocular pressure rise(2-3 weeks)

Study Sites (2)

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