PatientsVille.com LogoPatientsVille.com

Inflammation | Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Inflammation research study

What is the primary objective of this study?

Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. The investigators here compare the efficacy of single depot steroid subtenon injection (20-mg triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling inflammation after uneventful phacoemulsification.

Who is eligible to participate?

Inclusion Criteria: - Age older than 18 years old - Uncomplicated cataract patient scheduled for phacoemulsification and posterior chamber intraocular lens implantation - No History of prior intraocular procedures or any eye diseases such as uveitis, glaucoma, diabetic retinopathy - No History of systemic autoimmune diseases - No History of allergy to corticosteroids or to any component of the study medications - No History of using corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunomodulating agents within 3 months prior to surgery Exclusion Criteria: - Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus - Pregnant and lactating women

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Inflammation

Intraocular Pressure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Subtenon 20-mg triamcinolone injectionTreatment arm will receive single subtenon 20-mg triamcinolone with gentamicin injection after uneventful phacoemulsification. 0.3% Tobramycin eye drop will be given to treatment arm for 28 days to blind the patient.

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DexamethasoneDexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days

TriamcinoloneSubtenon 20-mg Triamcinolone injection

Study Status

Unknown status

Start Date: May 2012

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Anterior chamber reaction

Secondary Outcome: rate of increased intraocular pressure over 21 mmHg

Study sponsors, principal investigator, and references

Principal Investigator: Pitipol Choopong, MD

Lead Sponsor: Mahidol University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01801774

Discuss Aristospan