Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification
Primary Purpose
Ocular Inflammation
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
triamcinolone acetonide
Maxitriol
Sponsored by

About this trial
This is an interventional treatment trial for Ocular Inflammation focused on measuring orbital floor triamcinolone, phacoemulsification, post op inflammation, cmo
Eligibility 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
Sites / Locations
- Sligo General Hospital
Outcomes
Primary Outcome Measures
ocular inflammation
Secondary Outcome Measures
intraocular pressure
cystoid macular oedema
Full Information
NCT ID
NCT00789971
First Posted
November 11, 2008
Last Updated
November 12, 2008
Sponsor
Sligo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00789971
Brief Title
Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification
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 Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sligo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation
Keywords
orbital floor triamcinolone, phacoemulsification, post op inflammation, cmo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Other Intervention Name(s)
Kenelog
Intervention Description
40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification
Intervention Type
Drug
Intervention Name(s)
Maxitriol
Intervention Description
one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g
Primary Outcome Measure Information:
Title
ocular inflammation
Time Frame
one week and one month post op
Secondary Outcome Measure Information:
Title
intraocular pressure
Time Frame
one week and one month post op
Title
cystoid macular oedema
Time Frame
one month post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Mullaney, FRCOphth
Organizational Affiliation
Sligo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sligo General Hospital
City
Sligo
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
15522378
Citation
Paganelli F, Cardillo JA, Melo LA Jr, Oliveira AG, Skaf M, Costa RA; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-Tenon's capsule triamcinolone acetonide injection for the treatment of post-cataract surgery inflammation. Ophthalmology. 2004 Nov;111(11):2102-8. doi: 10.1016/j.ophtha.2004.04.026.
Results Reference
background
PubMed Identifier
16631060
Citation
Negi AK, Browning AC, Vernon SA. Single perioperative triamcinolone injection versus standard postoperative steroid drops after uneventful phacoemulsification surgery: Randomized controlled trial. J Cataract Refract Surg. 2006 Mar;32(3):468-74. doi: 10.1016/j.jcrs.2005.12.102.
Results Reference
background
Learn more about this trial
Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification
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