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Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01326585
Recruitment Status : Withdrawn (lack of funding)
First Posted : March 31, 2011
Last Update Posted : June 3, 2015
Information provided by:
University of Toronto

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Drug: Dexamethasone Sodium Phosphate Injection Drug: Saline Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
Study Start Date : April 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Dexamethasone
Subjects receive intravenous intraoperative dexamethasone
Drug: Dexamethasone Sodium Phosphate Injection
8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery

Placebo Comparator: Saline solution
Subjects receive intravenous intraoperative normal saline solution
Drug: Saline Injection
2cc of 0.9% normal saline, IV injection, 1-time dose during surgery

Primary Outcome Measures :
  1. Subjective Level of Postoperative Nausea [ Time Frame: At 1 and 7 days post-surgery ]
    Assessed through patient survey, measured by 10cm visual analogue scale

  2. 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

Secondary Outcome Measures :
  1. Subjective rating of post-operative lid edema [ Time Frame: At 1 and 7 days post-surgery ]
    Assessed by investigator, rated "mild", "moderate", or "severe"

  2. Subjective rating of postoperative chemosis [ Time Frame: 1 and 7 days post-surgery ]
    Assessed by investigator, recorded as "mild", "moderate", or "severe"

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-79 years old
  • Scheduled for scleral buckle surgery to treat a retinal detachment
  • Consent to participate in study

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326585

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University of Toronto
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Principal Investigator: Mark Mandelcorn, MD FRCSC University Health Network, Toronto
Principal Investigator: Rajeev Muni, MD FRCSC St. Michael's Hospital, Toronto
Principal Investigator: Daniel B Rootman, MSc MD University of Toronto

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Responsible Party: Dr. Mark Mandelcorn, University Health Network Identifier: NCT01326585     History of Changes
Other Study ID Numbers: 0911-A
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: January 2011
Keywords provided by University of Toronto:
Scleral Buckling
Post-operative Nausea and Vomiting
Additional relevant MeSH terms:
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Dexamethasone 21-phosphate
Retinal Detachment
Retinal Diseases
Eye Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action