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

U

University of Toronto

Status and phase

Withdrawn
Phase 4

Conditions

Retinal Detachment

Treatments

Drug: Dexamethasone Sodium Phosphate Injection
Drug: Saline Injection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Dexamethasone
Experimental group
Description:
Subjects receive intravenous intraoperative dexamethasone
Treatment:
Drug: Dexamethasone Sodium Phosphate Injection
Saline solution
Placebo Comparator group
Description:
Subjects receive intravenous intraoperative normal saline solution
Treatment:
Drug: Saline Injection

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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