Triamcinolone Assisted Anterior Vitrectomy
Primary Purpose
Vitrectomy, Cataract
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Intra ocular injection of triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Vitrectomy focused on measuring Triamcinolone acetenoide, anterior vitrectomy, presence of vitreous in the anterior chamber., effect of triamcinolone injection on IOP,intraocular infection
Eligibility 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
Sites / Locations
- El-Nour Eye hospital
- Kasr Al-Ainy Hospital Cairo university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Triamcinolone acetenoide
Arm Description
Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery
Outcomes
Primary Outcome Measures
Proper visualization of vitreous strands in the anterior chamber of the eye
Secondary Outcome Measures
intraocular pressure rise
Full Information
NCT ID
NCT01051648
First Posted
January 15, 2010
Last Updated
January 15, 2010
Sponsor
Cairo University
Collaborators
AL-Nour Eye Hospital, Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01051648
Brief Title
Triamcinolone Assisted Anterior Vitrectomy
Official Title
Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cairo University
Collaborators
AL-Nour Eye Hospital, Kasr El Aini Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitrectomy, Cataract
Keywords
Triamcinolone acetenoide, anterior vitrectomy, presence of vitreous in the anterior chamber., effect of triamcinolone injection on IOP,intraocular infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone acetenoide
Arm Type
Experimental
Arm Description
Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery
Intervention Type
Drug
Intervention Name(s)
Intra ocular injection of triamcinolone acetonide
Other Intervention Name(s)
kena cort
Intervention Description
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
Primary Outcome Measure Information:
Title
Proper visualization of vitreous strands in the anterior chamber of the eye
Time Frame
immediately
Secondary Outcome Measure Information:
Title
intraocular pressure rise
Time Frame
2-3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa A EL-Helw, M.D.
Organizational Affiliation
Cairo unuversity & EL-Nour eye hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed M Emarah, M.D.
Organizational Affiliation
Cairo university & EL-Nour eye hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
El-Nour Eye hospital
City
Cairo
ZIP/Postal Code
11371
Country
Egypt
Facility Name
Kasr Al-Ainy Hospital Cairo university
City
Cairo
ZIP/Postal Code
11451
Country
Egypt
12. IPD Sharing Statement
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Triamcinolone Assisted Anterior Vitrectomy
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