Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification

Conditions
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Inflammation, Intraocular Pressure

Intervention / Treatment
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* Drug: Subtenon 20-mg triamcinolone injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dexamethasone<br>Dexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days | Drug: Placebo<br> <br> |
| Active Comparator: Triamcinolone<br>Subtenon 20-mg Triamcinolone injection | Drug: Subtenon 20-mg triamcinolone injection<br>* Treatment 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.<br>* Other names: Triamcinolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber reaction | proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5 | postoperative day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of increased intraocular pressure over 21 mmHg | rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer | preoperative, postoperative day 1,7,14,28,90 | 
| Changes of anterior chamber reaction over time | repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90 | preoperative, postoperative day1, 7, 14, 28, 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroid, post-operative inflammation, intraocular pressure