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?
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.
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
Start Date: May 2012
Completed Date: July 2015
Phase: Phase 4
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