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

This study has been completed.
Sponsor:
Information provided by:
Hospital Governador Celso Ramos
ClinicalTrials.gov Identifier:
NCT01404364
First received: July 11, 2011
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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 Intervention
Blind Painful Eye
Refractory Glaucoma
Control of Pain Through Drug Injection
Drug: Triamcinolone
Drug: Chlorpromazine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye

Resource links provided by NLM:


Further study details as provided by Hospital Governador Celso Ramos:

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

  • Changes in Intraocular pressure (IOP) [ Time Frame: 0, 1 months, 3 months, 6 months ] [ Designated as safety issue: No ]
    IOP was measured at all times of patient evaluation


Enrollment: 36
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404364

Locations
Brazil
Hospital Governador Celso Ramos
Florianopolis, Santa Catarina, Brazil, 88015270
Sponsors and Collaborators
Hospital Governador Celso Ramos
Investigators
Principal Investigator: Deborah C Ribas, MD Hospital Governador Celso Ramos
  More Information

No publications provided

Responsible Party: Deborah Cristina Ribas, Hospital Governador Celso Ramos
ClinicalTrials.gov Identifier: NCT01404364     History of Changes
Other Study ID Numbers: HGCR-20101
Study First Received: July 11, 2011
Last Updated: July 27, 2011
Health Authority: Brazil: National Health Council

Keywords provided by Hospital Governador Celso Ramos:
Triamcinolone
Chlorpromazine
Refractory glaucoma
Blind painful eye

Additional relevant MeSH terms:
Glaucoma
Pain
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Ocular Hypertension
Signs and Symptoms
Chlorpromazine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 30, 2014