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Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00789971
Enrollment
150
Registered
2008-11-13
Start date
2007-03-31
Completion date
2008-04-30
Last updated
2008-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Inflammation

Keywords

orbital floor triamcinolone, phacoemulsification, post op inflammation, cmo

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.

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.

Interventions

DRUGtriamcinolone acetonide

40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification

DRUGMaxitriol

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

Sponsors

Sligo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ocular inflammationone week and one month post op

Secondary

MeasureTime frame
intraocular pressureone week and one month post op
cystoid macular oedemaone month post op

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026