Inflammation, Intraocular Pressure
Conditions
Keywords
post-operative inflammation, steroid, intraocular pressure
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.
Interventions
DRUGPlacebo
DRUGSubtenon 20-mg triamcinolone injection
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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior chamber reaction | postoperative day 28 | proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of increased intraocular pressure over 21 mmHg | preoperative, postoperative day 1,7,14,28,90 | rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer |
| Changes of anterior chamber reaction over time | preoperative, postoperative day1, 7, 14, 28, 90 | repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90 |
Countries
Thailand
Contacts
Primary ContactPitipol Choopong, MD
Outcome results
None listed