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

Phase 4

Withdrawn

• Conditions: Retinal Detachment
• Interventions: Drug: Dexamethasone Sodium Phosphate Injection; Drug: Saline Injection

• Registration Number: NCT01326585
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone Sodium Phosphate Injection	Subjects receive intravenous intraoperative dexamethasone
Saline solution	Saline Injection	Subjects receive intravenous intraoperative normal saline solution

Primary Outcome Measures

Name	Time	Method
Subjective Level of Postoperative Nausea	At 1 and 7 days post-surgery	Assessed through patient survey, measured by 10cm visual analogue scale
Subjective Level of Postoperative Pain	1 and 7 days post-surgery	Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method
Subjective rating of post-operative lid edema	At 1 and 7 days post-surgery	Assessed by investigator, rated "mild", "moderate", or "severe"
Subjective rating of postoperative chemosis	1 and 7 days post-surgery	Assessed by investigator, recorded as "mild", "moderate", or "severe"

Trial Locations

Locations (2)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada