Triamcinolone Assisted Anterior Vitrectomy

NCT ID: NCT01051648

Last Updated: 2010-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Vitrectomy Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triamcinolone acetenoide

Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery

Group Type EXPERIMENTAL

Intra ocular injection of triamcinolone acetonide

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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kena cort

Eligibility Criteria

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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
Minimum Eligible Age

47 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AL-Nour Eye Hospital

OTHER

Sponsor Role collaborator

Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Cairo university medical school. EL-Nour Eye hospital

Principal Investigators

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Mostafa A EL-Helw, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo unuversity & EL-Nour eye hospital

Ahmed M Emarah, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo university & EL-Nour eye hospital

Locations

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El-Nour Eye hospital

Cairo, , Egypt

Site Status

Kasr Al-Ainy Hospital Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Triam1

Identifier Type: -

Identifier Source: org_study_id

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