NCT00789971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 11, 2008

Last Update Submit

November 12, 2008

Conditions

Ocular Inflammation

Keywords

orbital floor triamcinolonephacoemulsificationpost op inflammationcmo

Outcome Measures

Primary Outcomes (1)

  • ocular inflammation

    one week and one month post op

Secondary Outcomes (2)

  • intraocular pressure

    one week and one month post op

  • cystoid macular oedema

    one month post op

Interventions

triamcinolone acetonideDRUG

40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification

Also known as: Kenelog
MaxitriolDRUG

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • uncomplicated cataract surgery, ability to attend follow appointments at one week and one month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sligo General Hospital

Sligo, Sligo, Ireland

Location

Related Publications (2)

  • Paganelli F, Cardillo JA, Melo LA Jr, Oliveira AG, Skaf M, Costa RA; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-Tenon's capsule triamcinolone acetonide injection for the treatment of post-cataract surgery inflammation. Ophthalmology. 2004 Nov;111(11):2102-8. doi: 10.1016/j.ophtha.2004.04.026.

    PMID: 15522378BACKGROUND

  • Negi AK, Browning AC, Vernon SA. Single perioperative triamcinolone injection versus standard postoperative steroid drops after uneventful phacoemulsification surgery: Randomized controlled trial. J Cataract Refract Surg. 2006 Mar;32(3):468-74. doi: 10.1016/j.jcrs.2005.12.102.

    PMID: 16631060BACKGROUND

MeSH Terms

Conditions

Chronic recurrent multifocal osteomyelitis

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Paul Mullaney, FRCOphth

    Sligo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

IE(1)