Clinical trial NCT01051648: Triamcinolone Assisted Anterior Vitrectomy
Official title: Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitrectomy
Cataract
Keywords: Triamcinolone acetenoide
anterior vitrectomy
presence of vitreous in the anterior chamber.
effect of triamcinolone injection on IOP,intraocular infection
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: AL-Nour Eye Hospital
name: Kasr El Aini Hospital
First posted: 2010-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 47
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proper visualization of vitreous strands in the anterior chamber of the eye
timeFrame: immediately
Secondary outcomes:
measure: intraocular pressure rise
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El-Nour Eye hospital
city: Cairo
country: Egypt
facility: Kasr Al-Ainy Hospital Cairo university
Study officials:
affiliation: Cairo unuversity & EL-Nour eye hospital
name: Mostafa A EL-Helw, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo university & EL-Nour eye hospital
name: Ahmed M Emarah, M.D.
role: PRINCIPAL_INVESTIGATOR
References: