Triamcinolone Assisted Anterior Vitrectomy
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| First Received Date ICMJE | January 15, 2010 | ||||||||
| Last Updated Date | January 15, 2010 | ||||||||
| Start Date ICMJE | December 2007 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
intraocular pressure rise [ Time Frame: 2-3 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Triamcinolone Assisted Anterior Vitrectomy | ||||||||
| Official Title ICMJE | Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction | ||||||||
| Brief Summary | Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Triamcinolone acetenoide
Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery
Intervention: Drug: Intra ocular injection of triamcinolone acetonide |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 10 | ||||||||
| Completion Date | June 2008 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 47 Years to 79 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Egypt | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01051648 | ||||||||
| Other Study ID Numbers ICMJE | Triam1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr.Mostafa A EL-Helw,assistant. professor of Ophthalmology Cairo university, Cairo university medical school. EL-Nour Eye hospital | ||||||||
| Study Sponsor ICMJE | Cairo University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Cairo University | ||||||||
| Verification Date | February 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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