Blind Painful EyeNCT01404364
Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
A study testing Triamcinolone and Chlorpromazine in people with Blind Painful Eye and Refractory Glaucoma, run by Hospital Governador Celso Ramos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Blind Painful Eye, Refractory Glaucoma, Control of Pain Through Drug Injection
- What is being tested?
- Triamcinolone and Chlorpromazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients treated in the period at HGCR who wanted to be part of the protocol by signing the consent form
Who cannot join
- patients whose follow-up period was less than three months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Governador Celso Ramos
Florianópolis, Santa Catarina, 88015270
About this study
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.
Read the 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.
- Being tested
- Triamcinolone, Chlorpromazine
- Keywords
- Triamcinolone, Chlorpromazine, Refractory glaucoma, Blind painful eye
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
0,3mL intravitreal injection of Triamcinolone, single dose
ChlorpromazineDrug
Also called Amplictil
2,5mL Chlorpromazine retrobulbar injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Triamcinolone | Active comparator | Patients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection Receives: Drug: Triamcinolone |
| Retrobulbar Chlorpromazine | Active comparator | Patients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection Receives: Drug: Chlorpromazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 1 month, 3 months, 6 months after procedure
Secondary outcomes (2)
Changes in Use of eyedrops before and after drug injection
Patient use of eyedrops before and after the procedure (yes or no)
Measured: 0, 1 month, 3 months, 6 months
Changes in Intraocular pressure (IOP)
IOP was measured at all times of patient evaluation
Measured: 0, 1 months, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blind Painful EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Governador Celso Ramos
- Sponsor type
- University, hospital or other
- Investigators
- Deborah C Ribas, MD, Principal investigator, Hospital Governador Celso Ramos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404364
- Sponsor's protocol ID
- HGCR-20101
- Status last verified
- Jul 2011
- First submitted
- 11 Jul 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
- ClinicalTrials.gov ID
- NCT01404364
- Acronym / sponsor ID
- HGCR-20101
- Keywords
- Triamcinolone, Chlorpromazine, Refractory glaucoma, Blind painful eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Governador Celso RamosUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Triamcinolone | Active comparator | Drug: TriamcinolonePatients with phthisis bulbi received 0,3ml intravitreal triamcinolone injection |
| Retrobulbar Chlorpromazine | Active comparator | Drug: ChlorpromazinePatients with refractory glaucoma and blind painful eye were submitted to 2,5mL Chlorpromazine retrobulbar injection |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients treated in the period at HGCR who wanted to be part of the protocol by signing the consent form
Key exclusion criteria (1 listed)
- patients whose follow-up period was less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone0,3mL intravitreal injection of Triamcinolone, single dose | Drug | Intravitreal Triamcinolone |
| ChlorpromazineAlso: Amplictil2,5mL Chlorpromazine retrobulbar injection, single dose | Drug | Retrobulbar Chlorpromazine |
Primary outcome
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
2 secondary outcomes
Changes in Use of eyedrops before and after drug injection
Time frame: 0, 1 month, 3 months, 6 months
Changes in Intraocular pressure (IOP)
Time frame: 0, 1 months, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah C Ribas, MD principal investigator
Hospital Governador Celso Ramos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone and Chlorpromazine in people with Blind Painful Eye and Refractory Glaucoma, run by Hospital Governador Celso Ramos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain intensity (time frame: 0, 1 month, 3 months, 6 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.