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Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

S

Sligo General Hospital

Status

Completed

Conditions

Ocular Inflammation

Treatments

Drug: triamcinolone acetonide
Drug: Maxitriol

Study type

Interventional

Funder types

Other

Identifiers

NCT00789971
Sligogh

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

40+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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