Triamcinolone Assisted Anterior Vitrectomy

This study has been completed.
Sponsor:
Collaborators:
El-Nour eye hospital
Kasr AL Ainy Hospital
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01051648
First received: January 15, 2010
Last updated: NA
Last verified: February 2008
History: No changes posted

January 15, 2010
January 15, 2010
December 2007
February 2008   (final data collection date for primary outcome measure)
Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
intraocular pressure rise [ Time Frame: 2-3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Triamcinolone Assisted Anterior Vitrectomy
Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction

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

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Vitrectomy
  • Cataract
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
47 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01051648
Triam1
Yes
Dr.Mostafa A EL-Helw,assistant. professor of Ophthalmology Cairo university, Cairo university medical school. EL-Nour Eye hospital
Cairo University
  • El-Nour eye hospital
  • Kasr AL Ainy Hospital
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
Cairo University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP