Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

This study has been completed.
Sponsor:
Information provided by:
Sligo General Hospital
ClinicalTrials.gov Identifier:
NCT00789971
First received: November 11, 2008
Last updated: November 12, 2008
Last verified: November 2008
  Purpose

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 Intervention
Ocular Inflammation
Drug: triamcinolone acetonide
Drug: Maxitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Sligo General Hospital:

Primary Outcome Measures:
  • ocular inflammation [ Time Frame: one week and one month post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intraocular pressure [ Time Frame: one week and one month post op ] [ Designated as safety issue: No ]
  • cystoid macular oedema [ Time Frame: one month post op ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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
    Other Name: Maxitriol
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789971

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

Publications:
Responsible Party: Catherine Prendiville, Ophthalmolgy Department, Sligo General Hospital
ClinicalTrials.gov Identifier: NCT00789971     History of Changes
Other Study ID Numbers: Sligogh
Study First Received: November 11, 2008
Last Updated: November 12, 2008
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Sligo General Hospital:
orbital floor triamcinolone
phacoemulsification
post op inflammation
cmo

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014