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Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

Information source: Sligo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ocular Inflammation

Intervention: triamcinolone acetonide (Drug); Maxitriol (Drug)

Phase: N/A

Status: Completed

Sponsored by: Sligo General Hospital

Official(s) and/or principal investigator(s):
Paul Mullaney, FRCOphth, Study Director, Affiliation: Sligo General Hospital


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.

Clinical Details

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

Primary outcome: ocular inflammation

Secondary outcome:

intraocular pressure

cystoid macular oedema

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.


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Sligo General Hospital, Sligo, Ireland
Additional Information

Related 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.

Starting date: March 2007
Last updated: November 12, 2008

Page last updated: August 23, 2015

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