Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of a Single Orbital Floor Injection of Triamcinolone Versus Conventional Steroid and Antibiotic Drops Used Post Operatively in Uneventful Phacoemulsification Surgery

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Drug: triamcinolone acetonide
* Drug: Maxitriol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular inflammation |  | one week and one month post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | one week and one month post op | 
| cystoid macular oedema |  | one month post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orbital floor triamcinolone, phacoemulsification, post op inflammation, cmo