Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Inflammation; Intraocular Pressure

Treatments: Drug: Placebo; Drug: Subtenon 20-mg triamcinolone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01801774

Si234/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups, including a placebo group

Dexamethasone

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Triamcinolone

Active Comparator group

Description:

Subtenon 20-mg Triamcinolone injection

Treatment:

Drug: Subtenon 20-mg triamcinolone injection