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

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.

Study Overview

• Status: Completed
• Conditions: Refractory Glaucoma; Blind Painful Eye; Control of Pain Through Drug Injection
• Intervention / Treatment: Drug: Triamcinolone; Drug: Chlorpromazine

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil, 88015270
      • Hospital Governador Celso Ramos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravitreal Triamcinolone; Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection	Drug: Triamcinolone; 0,3mL intravitreal injection of Triamcinolone, single dose
Active Comparator: Retrobulbar Chlorpromazine; Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection	Drug: Chlorpromazine; 2,5mL Chlorpromazine retrobulbar injection, single dose; Other Names: Amplictil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in Intraocular pressure (IOP)	IOP was measured at all times of patient evaluation	0, 1 months, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Hospital Governador Celso Ramos
• Investigators: Principal Investigator: Deborah C Ribas, MD, Hospital Governador Celso Ramos

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 27, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Triamcinolone; Chlorpromazine; Refractory glaucoma; Blind painful eye
• Additional Relevant MeSH Terms: Eye Diseases; Neurologic Manifestations; Ocular Hypertension; Glaucoma; Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Triamcinolone; Chlorpromazine
• Other Study ID Numbers: HGCR-20101