Triamcinolone Assisted Anterior Vitrectomy
|ClinicalTrials.gov Identifier: NCT01051648|
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|Vitrectomy Cataract||Drug: Intra ocular injection of triamcinolone acetonide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ]
- intraocular pressure rise [ Time Frame: 2-3 weeks ]
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
|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|