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Triamcinolone Assisted Anterior Vitrectomy

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ClinicalTrials.gov Identifier: NCT01051648
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Collaborators:
AL-Nour Eye Hospital
Kasr El Aini Hospital
Information provided by:
Cairo University

Study Description
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Brief Summary:
Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.

Condition or disease Intervention/treatment Phase
Vitrectomy Cataract Drug: Intra ocular injection of triamcinolone acetonide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction
Study Start Date : December 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Triamcinolone acetenoide
Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery
 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
Other Name: kena cort


Outcome Measures
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Primary Outcome Measures :
  1. Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ]

Secondary Outcome Measures :
  1. intraocular pressure rise [ Time Frame: 2-3 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   47 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051648


Locations
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Egypt
El-Nour Eye hospital
Cairo, Egypt, 11371
Kasr Al-Ainy Hospital Cairo university
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
AL-Nour Eye Hospital
Kasr El Aini Hospital
Investigators
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Principal Investigator: Mostafa A EL-Helw, M.D. Cairo unuversity & EL-Nour eye hospital
Principal Investigator: Ahmed M Emarah, M.D. Cairo university & EL-Nour eye hospital
More Information
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Responsible Party: Dr.Mostafa A EL-Helw,assistant. professor of Ophthalmology Cairo university, Cairo university medical school. EL-Nour Eye hospital
ClinicalTrials.gov Identifier: NCT01051648    
Other Study ID Numbers: Triam1
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: February 2008
Keywords provided by Cairo University:
Triamcinolone acetenoide
anterior vitrectomy
presence of vitreous in the anterior chamber.
effect of triamcinolone injection on IOP,intraocular infection
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action