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Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

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ClinicalTrials.gov Identifier: NCT00789971
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:
Sligo General Hospital

Study Description
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Brief Summary:

Cataract extraction is one of the most common operative procedures performed throughout the world. Conventionally, patients are discharged with postoperative drops of steroids and antibiotics or a combination of both. These drops are to be administered for 2-6 weeks depending on individual eye unit protocol. Many patients find the postoperative drops arduous and non-compliance can cause prolonged inflammation and discomfort. Patients with cognitive, physical and visual impairments require assistance from family or community nurses to administer drops. A single perioperative injection of Triamcinolone has been shown to be an effective replacement for drops postoperatively in two previous studies 1, 2.

Aims & objectives

The aim of this study is to see if a single orbital floor injection of Triamcinolone is equivalent to conventional steroid and antibiotic drops used post operatively in uneventful phacoemulsification surgery in treating postoperative inflammation.


Condition or disease Intervention/treatment Phase
Ocular Inflammation Drug: triamcinolone acetonide Drug: Maxitriol Not Applicable

Detailed Description:
This is a prospective randomized control trial of 80 patients undergoing routine phacoemulsification cataract extraction. The patients were randomly assigned to receive the triamcinolone injection or post operative topical treatment of G Maxitriol QDS 1/52 tapering over one month. Forty mg of triamcinolone was injected inferior temporally immediately post operatively prior to undraping the patient in theatre in those randomized to this group. The patients were reviewed at week one and at one month.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of a Single Orbital Floor Injection of Triamcinolone Versus Conventional Steroid and Antibiotic Drops Used Post Operatively in Uneventful Phacoemulsification Surgery
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: triamcinolone acetonide
    40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification
    Other Name: Kenelog
  • Drug: Maxitriol
    one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g

Outcome Measures
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Primary Outcome Measures :
  1. ocular inflammation [ Time Frame: one week and one month post op ]

Secondary Outcome Measures :
  1. intraocular pressure [ Time Frame: one week and one month post op ]
  2. cystoid macular oedema [ Time Frame: one month post op ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • uncomplicated cataract surgery, ability to attend follow appointments at one week and one month

Exclusion Criteria:

  • included premorbid ocular pathology including previous ocular inflammation and glaucoma, previous ocular surgery, history of CMO, diabetes, concurrent use of systemic anti-inflammatories including inhaled or topical therapy, history of systemic inflammation, inability to attend follow up appointments at one week and one month, complicated cataract surgery
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00789971


Locations
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Ireland
Sligo General Hospital
Sligo, Ireland
Sponsors and Collaborators
Sligo General Hospital
Investigators
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Study Director: Paul Mullaney, FRCOphth Sligo General Hospital
More Information
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Publications:

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Responsible Party: Catherine Prendiville, Ophthalmolgy Department, Sligo General Hospital
ClinicalTrials.gov Identifier: NCT00789971    
Other Study ID Numbers: Sligogh
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Keywords provided by Sligo General Hospital:
orbital floor triamcinolone
phacoemulsification
post op inflammation
cmo
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action