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

Not Applicable

Completed

• Conditions: Blind Painful Eye; Refractory Glaucoma; Control of Pain Through Drug Injection
• Interventions: Drug: Triamcinolone; Drug: Chlorpromazine

• Registration Number: NCT01404364
• Lead Sponsor: Hospital Governador Celso Ramos

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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-27
• Last Update Submitted: 2011-07-27
• Study First Posted: 2011-07-28
• Last Update Posted: 2011-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal Triamcinolone	Triamcinolone	Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection
Retrobulbar Chlorpromazine	Chlorpromazine	Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection

Primary Outcome Measures

Name	Time	Method
Changes in Pain intensity	0, 1 month, 3 months, 6 months after procedure	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

Secondary Outcome Measures

Name	Time	Method
Changes in Use of eyedrops before and after drug injection	0, 1 month, 3 months, 6 months	Patient use of eyedrops before and after the procedure (yes or no)
Changes in Intraocular pressure (IOP)	0, 1 months, 3 months, 6 months	IOP was measured at all times of patient evaluation

Trial Locations

Locations (1)

Hospital Governador Celso Ramos; 🇧🇷 Florianopolis, Santa Catarina, Brazil