Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye

NCT01404364 | Completed

• 1 other identifier: HGCR-20101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.

Conditions

Blind Painful Eye; Refractory Glaucoma; Control of Pain Through Drug Injection

Keywords

Triamcinolone; Chlorpromazine; Refractory glaucoma; Blind painful eye

Outcome Measures

Primary Outcomes (1)

• Changes in Pain intensity

  Pain was measured asking the patient to graduate it in a scale from 0 to 10, 0 being no pain, 10 being the worst pain patient has experienced in life

  0, 1 month, 3 months, 6 months after procedure

Secondary Outcomes (2)

• Changes in Use of eyedrops before and after drug injection

  0, 1 month, 3 months, 6 months

• Changes in Intraocular pressure (IOP)

  0, 1 months, 3 months, 6 months

Study Arms (2)

Intravitreal Triamcinolone

ACTIVE COMPARATOR

Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection

Drug: Triamcinolone

Retrobulbar Chlorpromazine

ACTIVE COMPARATOR

Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection

Drug: Chlorpromazine

Interventions

Triamcinolone DRUG

0,3mL intravitreal injection of Triamcinolone, single dose

Intravitreal Triamcinolone

Chlorpromazine DRUG

2,5mL Chlorpromazine retrobulbar injection, single dose

Also known as: Amplictil

Retrobulbar Chlorpromazine

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients treated in the period at HGCR who wanted to be part of the protocol by signing the consent form

You may not qualify if:

• patients whose follow-up period was less than three months

Sponsors & Collaborators

• Hospital Governador Celso Ramos: lead

Study Sites (1)

Hospital Governador Celso Ramos

Florianópolis, Santa Catarina, 88015270, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Triamcinolone; Chlorpromazine

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Deborah C Ribas, MD

  Hospital Governador Celso Ramos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 28, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

BR (1)