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
  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

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051648

Locations
Egypt
El-Nour Eye hospital
Cairo, Egypt, 11371
Kasr Al-Ainy Hospital Cairo university
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
El-Nour eye hospital
Kasr AL Ainy Hospital
Investigators
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 April 17, 2014