Retinal DetachmentPhase 4NCT01326585
Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection and Saline Injection in people with Retinal Detachment, run by University of Toronto at 2 sites in Canada.
Trial summary
Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Dexamethasone Sodium Phosphate Injection and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2011to Apr 2012
- Phase
- Phase 4
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-79 years old
- Scheduled for scleral buckle surgery to treat a retinal detachment
- Consent to participate in study
Who cannot join
- Pregnant or nursing
- Prior treatment with steroids
- Severe diabetes mellitus (HbA1c > 8%)
- Use of opioids, sedatives, or any kind of analgesics <1 week before scleral buckling surgery
- History of alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.
- Conditions
- Retinal Detachment
- Being tested
- Dexamethasone Sodium Phosphate Injection, Saline Injection
- Keywords
- Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting
- Medical subject headings
- Retinal Detachment, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate InjectionDrug
8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery
Saline InjectionDrug
2cc of 0.9% normal saline, IV injection, 1-time dose during surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Subjects receive intravenous intraoperative dexamethasone Receives: Drug: Dexamethasone Sodium Phosphate Injection |
| Saline solution | Placebo comparator | Subjects receive intravenous intraoperative normal saline solution Receives: Drug: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Level of Postoperative Nausea
Assessed through patient survey, measured by 10cm visual analogue scale
Measured: At 1 and 7 days post-surgery
Subjective Level of Postoperative Pain
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale
Measured: 1 and 7 days post-surgery
Secondary outcomes (2)
Subjective rating of post-operative lid edema
Assessed by investigator, rated "mild", "moderate", or "severe"
Measured: At 1 and 7 days post-surgery
Subjective rating of postoperative chemosis
Assessed by investigator, recorded as "mild", "moderate", or "severe"
Measured: 1 and 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Mark Mandelcorn, MD FRCSC, Principal investigator, University Health Network, TorontoRajeev Muni, MD FRCSC, Principal investigator, Unity Health TorontoDaniel B Rootman, MSc MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326585
- Sponsor's protocol ID
- 0911-A
- Status last verified
- Jan 2011
- First submitted
- 28 Mar 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01326585
- Acronym / sponsor ID
- 0911-A
- Conditions
- Retinal Detachment
- Keywords
- Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 31 Mar 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.
Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone Sodium Phosphate InjectionSubjects receive intravenous intraoperative dexamethasone |
| Saline solution | Placebo comparator | Drug: Saline InjectionSubjects receive intravenous intraoperative normal saline solution |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-79 years old
- Scheduled for scleral buckle surgery to treat a retinal detachment
- Consent to participate in study
Key exclusion criteria (5 listed)
- Pregnant or nursing
- Prior treatment with steroids
- Severe diabetes mellitus (HbA1c > 8%)
- Use of opioids, sedatives, or any kind of analgesics <1 week before scleral buckling surgery
- History of alcohol or drug abuse
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 |
|---|---|---|
| Dexamethasone Sodium Phosphate Injection8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery | Drug | Dexamethasone |
| Saline Injection2cc of 0.9% normal saline, IV injection, 1-time dose during surgery | Drug | Saline solution |
Primary outcome
Subjective Level of Postoperative Nausea
Time frame: At 1 and 7 days post-surgery
Assessed through patient survey, measured by 10cm visual analogue scale
Subjective Level of Postoperative Pain
Time frame: 1 and 7 days post-surgery
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale
2 secondary outcomes
Subjective rating of post-operative lid edema
Time frame: At 1 and 7 days post-surgery
Subjective rating of postoperative chemosis
Time frame: 1 and 7 days post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
Related trials for Retinal Detachment
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Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Mark Mandelcorn, MD FRCSC principal investigator
University Health Network, Toronto
Rajeev Muni, MD FRCSC principal investigator
Unity Health Toronto
Daniel B Rootman, MSc MD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection and Saline Injection in people with Retinal Detachment, run by University of Toronto at 2 sites in Canada.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Subjective Level of Postoperative Nausea (time frame: At 1 and 7 days post-surgery). The study lists 2 primary outcomes in all. 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 3 Jun 2015.