Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

Sponsor

Sligo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00789971

Collaborator

(none)

150

Enrollment

Location

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Inflammation	Drug: triamcinolone acetonide Drug: Maxitriol	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

ocular inflammation [one week and one month post op]

Secondary Outcome Measures

intraocular pressure [one week and one month post op]
cystoid macular oedema [one month post op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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