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

Sponsor

Hospital Governador Celso Ramos (Other)

Overall Status

Completed

CT.gov ID

NCT01404364

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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 Names: Amplictil

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 Names:

Amplictil

Outcome Measures

Primary Outcome Measures

Changes in Pain intensity [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

Changes in Use of eyedrops before and after drug injection [0, 1 month, 3 months, 6 months]
Patient use of eyedrops before and after the procedure (yes or no)
Changes in Intraocular pressure (IOP) [0, 1 months, 3 months, 6 months]
IOP was measured at all times of patient evaluation