Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

Ocular Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789971
• Other study ID #: Sligogh
• Status: Completed
• Phase: N/A
• First received: November 11, 2008
• Last updated: November 12, 2008
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2008
• Source: Sligo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation

Intervention

Drug:
• triamcinolone acetonide
40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification
• Maxitriol
one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g

Locations

Country	Name	City	State
Ireland	Sligo General Hospital	Sligo

Sponsors (1)

Lead Sponsor	Collaborator
Sligo General Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular inflammation		one week and one month post op	No
Secondary	intraocular pressure		one week and one month post op	No
Secondary	cystoid macular oedema		one month post op	No