Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification - Full Text View

Sponsored by:	Sligo General Hospital
Information provided by:	Sligo General Hospital
ClinicalTrials.gov Identifier:	NCT00789971

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

MedlinePlus related topics: Antibiotics

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Neomycin Neomycin sulfate Neomycin palmitate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
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

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:

40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification

one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g

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:

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.

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.

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

Keywords provided by Sligo General Hospital:

orbital floor triamcinolone
phacoemulsification
post op inflammation
cmo

Study placed in the following topic categories:

Dexamethasone
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate

Neomycin
Dexamethasone acetate
Triamcinolone hexacetonide
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009