Clinical trial NCT01801774: Efficacy Comparison Study of Steroids to Control Post-operative Inflammation
Official title: Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inflammation
Intraocular Pressure
Keywords: post-operative inflammation
steroid
intraocular pressure
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Cataract is one of the most common causes of blindness in the world. Surgical removal of lens is the only treatment for cataract, which now shifts from extracapsular cataract extraction to phacoemulsification. Although phacoemulsification provides faster operating time and gives better optical result and rapid recovery to the patient, it causes more inflammation post-operatively compare with extracapsular cataract extraction. Corticosteroids eye drops are mainly use to control intraocular inflammation after the surgery.

Other routes of corticosteroids have been introduced to increase the intraocular level and to increase the patient's compliance. Subtenon triamcinolone injection is easy and safe. Antiinflammatory effect of single subtenon triamcinolone injection lasts about 4-6 weeks. This method has been used in combination with corticosteroid eye drop to control the inflammation after cataract surgery in uveitic patients. It shows potency in controlling of intraocular inflammation with lower rate of increasing the intraocular pressure. The investigators here quantitatively compare the efficacy of subtenon 20-mg triamcinolone injection with 0.1% dexamethasone eye drop in controlling intraocular inflammation after uneventful phacoemulsification.

Eligibility criteria: 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

Primary outcomes:
measure: Anterior chamber reaction
timeFrame: postoperative day 28
Secondary outcomes:
measure: rate of increased intraocular pressure over 21 mmHg
timeFrame: preoperative, postoperative day 1,7,14,28,90
measure: Changes of anterior chamber reaction over time
timeFrame: preoperative, postoperative day1, 7, 14, 28, 90
Other outcomes:
Locations:
city: Bangkok-Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Pitipol Choopong, MD
role: PRINCIPAL_INVESTIGATOR
References: