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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

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE July 28, 2011
Last Update Posted Date July 28, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
  • 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)
  • Changes in Intraocular pressure (IOP) [ Time Frame: 0, 1 months, 3 months, 6 months ]
    IOP was measured at all times of patient evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
Official Title  ICMJE Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Blind Painful Eye
  • Refractory Glaucoma
  • Control of Pain Through Drug Injection
Intervention  ICMJE
  • Drug: Triamcinolone
    0,3mL intravitreal injection of Triamcinolone, single dose
  • Drug: Chlorpromazine
    2,5mL Chlorpromazine retrobulbar injection, single dose
    Other Name: Amplictil
Study Arms  ICMJE
  • Active Comparator: Intravitreal Triamcinolone
    Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection
    Intervention: Drug: Triamcinolone
  • Active Comparator: Retrobulbar Chlorpromazine
    Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection
    Intervention: Drug: Chlorpromazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2011)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01404364
Other Study ID Numbers  ICMJE HGCR-20101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deborah Cristina Ribas, Hospital Governador Celso Ramos
Study Sponsor  ICMJE Hospital Governador Celso Ramos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah C Ribas, MD Hospital Governador Celso Ramos
PRS Account Hospital Governador Celso Ramos
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP