Triamcinolone Assisted Anterior Vitrectomy

• ClinicalTrials.gov Identifier: NCT01051648
• Recruitment Status: Completed
• First Posted: January 18, 2010
• Last Update Posted: January 18, 2010
• Sponsor: Cairo University
• Collaborators: AL-Nour Eye Hospital; Kasr El Aini Hospital
• Information provided by: Cairo University

Tracking Information

• First Submitted Date: January 15, 2010
• First Posted Date: January 18, 2010
• Last Update Posted Date: January 18, 2010
• Study Start Date: December 2007
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 15, 2010): Proper visualization of vitreous strands in the anterior chamber of the eye [ Time Frame: immediately ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 15, 2010): intraocular pressure rise [ Time Frame: 2-3 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Triamcinolone Assisted Anterior Vitrectomy
• Official Title: Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Vitrectomy
• Cataract

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2010): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 47 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT01051648
• Other Study ID Numbers: Triam1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr.Mostafa A EL-Helw,assistant. professor of Ophthalmology Cairo university, Cairo university medical school. EL-Nour Eye hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Cairo University
• Original Study Sponsor: Same as current

Collaborators

• AL-Nour Eye Hospital
• Kasr El Aini 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

• PRS Account: Cairo University
• Verification Date: February 2008