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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Triamcinolone

Chlorpromazine

About this trial

This is an interventional supportive care trial for Blind Painful Eye focused on measuring Triamcinolone, Chlorpromazine, Refractory glaucoma, Blind painful eye

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Governador Celso Ramos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intravitreal Triamcinolone

Retrobulbar Chlorpromazine

Arm Description

Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection

Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Use of eyedrops before and after drug injection

Patient use of eyedrops before and after the procedure (yes or no)

Changes in Intraocular pressure (IOP)

IOP was measured at all times of patient evaluation

Full Information

NCT ID

NCT01404364

First Posted

July 11, 2011

Last Updated

July 27, 2011

Sponsor

Hospital Governador Celso Ramos

1. Study Identification

Unique Protocol Identification Number

NCT01404364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Governador Celso Ramos

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Triamcinolone, Chlorpromazine, Refractory glaucoma, Blind painful eye

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravitreal Triamcinolone

Arm Type

Active Comparator

Arm Description

Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection

Arm Title

Retrobulbar Chlorpromazine

Arm Type

Active Comparator

Arm Description

Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Intervention Description

0,3mL intravitreal injection of Triamcinolone, single dose

Intervention Type

Drug

Intervention Name(s)

Chlorpromazine

Other Intervention Name(s)

Amplictil

Intervention Description

2,5mL Chlorpromazine retrobulbar injection, single dose

Primary Outcome Measure Information:

Title

Changes in Pain intensity

Description

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

Time Frame

0, 1 month, 3 months, 6 months after procedure

Secondary Outcome Measure Information:

Title

Changes in Use of eyedrops before and after drug injection

Description

Patient use of eyedrops before and after the procedure (yes or no)

Time Frame

0, 1 month, 3 months, 6 months

Title

Changes in Intraocular pressure (IOP)

Description

IOP was measured at all times of patient evaluation

Time Frame

0, 1 months, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah C Ribas, MD

Organizational Affiliation

Hospital Governador Celso Ramos

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Governador Celso Ramos

City

Florianopolis

State/Province

Santa Catarina

ZIP/Postal Code

88015270

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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