NCT01051648

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
Last Updated

January 18, 2010

Status Verified

February 1, 2008

Enrollment Period

2 months

First QC Date

January 15, 2010

Last Update Submit

January 15, 2010

Conditions

VitrectomyCataract

Keywords

Triamcinolone acetenoideanterior vitrectomypresence of vitreous in the anterior chamber.effect of triamcinolone injection on IOP,intraocular infection

Outcome Measures

Primary Outcomes (1)

  • Proper visualization of vitreous strands in the anterior chamber of the eye

    immediately

Secondary Outcomes (1)

  • intraocular pressure rise

    2-3 weeks

Study Arms (1)

Triamcinolone acetenoide

EXPERIMENTAL

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

Interventions

Intra ocular injection of triamcinolone acetonideDRUG

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

Also known as: kena cort
Triamcinolone acetenoide

Eligibility Criteria

Age47 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with vitreous in the anterior chamber whether in
  • complicated cataract surgery
  • disorganized anterior segment structures

You may not qualify if:

  • Glaucoma patients
  • Intra ocular infections
  • Bacterial or fungal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

El-Nour Eye hospital

Cairo, 11371, Egypt

Location

Kasr Al-Ainy Hospital Cairo university

Cairo, 11451, Egypt

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

January 18, 2010

Record last verified: 2008-02

Locations

EG(2)