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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blind Painful Eye, Refractory Glaucoma, Control of Pain Through Drug Injection

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Chlorpromazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triamcinolone, Chlorpromazine, Refractory glaucoma, Blind painful eye