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

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ClinicalTrials.gov Identifier: NCT01404364
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : July 28, 2011
Sponsor:
Information provided by:
Hospital Governador Celso Ramos

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blind Painful Eye Refractory Glaucoma Control of Pain Through Drug Injection Drug: Triamcinolone Drug: Chlorpromazine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Amplictil


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Pain intensity [ Time Frame: 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 :
  1. Changes in Use of eyedrops before and after drug injection [ Time Frame: 0, 1 month, 3 months, 6 months ]
    Patient use of eyedrops before and after the procedure (yes or no)

  2. Changes in Intraocular pressure (IOP) [ Time Frame: 0, 1 months, 3 months, 6 months ]
    IOP was measured at all times of patient evaluation


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404364


Locations
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Brazil
Hospital Governador Celso Ramos
Florianopolis, Santa Catarina, Brazil, 88015270
Sponsors and Collaborators
Hospital Governador Celso Ramos
Investigators
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Principal Investigator: Deborah C Ribas, MD Hospital Governador Celso Ramos
More Information
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Responsible Party: Deborah Cristina Ribas, Hospital Governador Celso Ramos
ClinicalTrials.gov Identifier: NCT01404364    
Other Study ID Numbers: HGCR-20101
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011
Keywords provided by Hospital Governador Celso Ramos:
Triamcinolone
Chlorpromazine
Refractory glaucoma
Blind painful eye
Additional relevant MeSH terms:
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Glaucoma
Pain
Ocular Hypertension
Eye Diseases
Neurologic Manifestations
Triamcinolone
Chlorpromazine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents