Triamcinolone Assisted Anterior Vitrectomy
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Purpose
Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitrectomy Cataract |
Drug: Intra ocular injection of triamcinolone acetonide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction |
- Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
- intraocular pressure rise [ Time Frame: 2-3 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 47 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Egypt | |
| El-Nour Eye hospital | |
| Cairo, Egypt, 11371 | |
| Kasr Al-Ainy Hospital Cairo university | |
| Cairo, Egypt, 11451 | |
| 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
No publications provided
| 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 History of Changes |
| Other Study ID Numbers: | Triam1 |
| Study First Received: | January 15, 2010 |
| Last Updated: | January 15, 2010 |
| Health Authority: | Egypt: Ministry of Health, Drug Policy and Planning Center |
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:
|
Cataract Lens Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013