NCT00491712

Brief Summary

The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and surgery is frequently needed to control IOP. The success rates of a drainage device is usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections acetate has been used to treat macular edema secondary to diabetic retinopathy and central retinal vein occlusion and also to control inflammation in ophthalmologic surgeries. In the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

June 26, 2007

Status Verified

March 1, 2007

First QC Date

June 25, 2007

Last Update Submit

June 25, 2007

Conditions

Neovascular Glaucoma

Keywords

GlaucomaNeovascular GlaucomaDrainage implant devicesSilicone Ahmed TubeTriamcinolone

Outcome Measures

Primary Outcomes (1)

  • intra ocular pressure after the surgery in both groups

    monthly

Secondary Outcomes (1)

  • complication rates after surgery

    monthly

Interventions

Glaucoma drainage implant with/without triamcinolonePROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with NVG and uncontrolled IOP despite the use of maximum tolerated glaucoma medication
  • Patients over 18 years old.
  • Patients who can understand and sign the inform consent form.

You may not qualify if:

  • Active Sclerites
  • Uveitic Neovascular glaucoma
  • Previous psiquiatric condition
  • Patients who can understand and sign the inform consent form
  • Visual acuity worse than hand motion
  • Previous retina surgery with buckle implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

Related Publications (1)

  • Sivak-Callcott JA, O'Day DM, Gass JD, Tsai JC. Evidence-based recommendations for the diagnosis and treatment of neovascular glaucoma. Ophthalmology. 2001 Oct;108(10):1767-76; quiz1777, 1800. doi: 10.1016/s0161-6420(01)00775-8.

    PMID: 11581047BACKGROUND

MeSH Terms

Conditions

Glaucoma, NeovascularGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Augusto Paranhos Jr, PHD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

September 1, 2005

Study Completion

June 1, 2007

Last Updated

June 26, 2007

Record last verified: 2007-03

Locations

BR(1)