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Completed

NCT Number: NCT00789971

Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

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.

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Key information

Conditions

Ocular Inflammation Chronic recurrent multifocal osteomyelitis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sligo General Hospital

Sligo, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone Acetonide

Drug

40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification

Other names: Kenelog

Maxitriol

Drug

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

Primary outcomes

  1. ocular inflammation

    Time frame: one week and one month post op

Secondary outcomes

  1. intraocular pressure

    Time frame: one week and one month post op

  2. cystoid macular oedema

    Time frame: one month post op

Sponsors and collaborators

Lead sponsor

Sligo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 13, 2008
Registry last updated
Nov 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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