MedTrace Logo

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

NCT01326585 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-06-03

No results posted yet for this study

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.

Conditions

  • Retinal Detachment

Interventions

DRUG

Dexamethasone Sodium Phosphate Injection

8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery

DRUG

Saline Injection

2cc of 0.9% normal saline, IV injection, 1-time dose during surgery

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Mark Mandelcorn, MD FRCSC · University Health Network, Toronto

  • Rajeev Muni, MD FRCSC · Unity Health Toronto

  • Daniel B Rootman, MSc MD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326585 on ClinicalTrials.gov