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

Refractory Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404364
• Other study ID #: HGCR-20101
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: July 27, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Hospital Governador Celso Ramos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Council
• Study type: Interventional

Clinical Trial 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.

Description:

The management of chronic eye pain is a constant challenge to ophthalmology. Treatment varies with the intensity of pain, and topical eye drops and contact lens therapy are effective in many patients. In refractory cases, and without vision, surgical removal of the eye through enucleation is considered classical therapy. As less invasive alternatives we have cyclodestruction and neurolytic drug injection in order to promote analgesia for a prolonged period.

The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of This is a prospective study of patients with blind painful eyes not responsive to topical treatment and with no indication for evisceration seen at the Department of Ophthalmology, Hospital Governador Celso Ramos (HGCR) in 2010.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• Triamcinolone
0,3mL intravitreal injection of Triamcinolone, single dose
• Chlorpromazine
2,5mL Chlorpromazine retrobulbar injection, single dose

Locations

Country	Name	City	State
Brazil	Hospital Governador Celso Ramos	Florianopolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Governador Celso Ramos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in Use of eyedrops before and after drug injection	Patient use of eyedrops before and after the procedure (yes or no)	0, 1 month, 3 months, 6 months	No
Secondary	Changes in Intraocular pressure (IOP)	IOP was measured at all times of patient evaluation	0, 1 months, 3 months, 6 months	No