Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
This study has been completed.
Sponsor:
Hospital Governador Celso Ramos
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
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
Drug Information available for:
Chlorpromazine
Triamcinolone diacetate
Chlorpromazine hydrochloride
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
U.S. FDA Resources
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
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 Ocular Hypertension Eye Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms Chlorpromazine Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids |
ClinicalTrials.gov processed this record on June 18, 2013