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

June 2, 2015 updated by: University of Toronto

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5C 2T2
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Daniel B Rootman, MSc MD, University of Toronto
  • Principal Investigator: Mark Mandelcorn, MD FRCSC, University Health Network, Toronto
  • Principal Investigator: Rajeev Muni, MD FRCSC, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0911-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Detachment

Clinical Trials on Dexamethasone Sodium Phosphate Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe