MedDataX Logo

Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

NCT ID: NCT00789971

Last Updated: 2008-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

orbital floor triamcinolone phacoemulsification post op inflammation cmo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

triamcinolone acetonide

40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification

Intervention Type DRUG

Maxitriol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kenelog

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sligo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ophthalmolgy Department, Sligo General Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Mullaney, FRCOphth

Role: STUDY_DIRECTOR

Sligo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sligo General Hospital

Sligo, Sligo, Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15522378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16631060 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Sligogh

Identifier Type: -

Identifier Source: org_study_id