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Triamcinolone Assisted Anterior Vitrectomy

Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitrectomy; Cataract

Intervention: Intra ocular injection of triamcinolone acetonide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cairo University

Official(s) and/or principal investigator(s):
Mostafa A EL-Helw, M.D., Principal Investigator, Affiliation: Cairo unuversity & EL-Nour eye hospital
Ahmed M Emarah, M.D., Principal Investigator, Affiliation: Cairo university & EL-Nour eye hospital

Summary

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

Clinical Details

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

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

Primary outcome: Proper visualization of vitreous strands in the anterior chamber of the eye

Secondary outcome: intraocular pressure rise

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.

Eligibility

Minimum age: 47 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

El-Nour Eye hospital, Cairo 11371, Egypt

Kasr Al-Ainy Hospital Cairo university, Cairo 11451, Egypt

Additional Information

Starting date: December 2007
Last updated: January 15, 2010

Page last updated: August 23, 2015

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