Efficacy Comparison Study of Steroids to Control Post-operative Inflammation
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammation; Intraocular Pressure
Intervention: Subtenon 20-mg triamcinolone injection (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Pitipol Choopong, MD, Principal Investigator, Affiliation: Mahidol University
Overall contact: Pitipol Choopong, MD, Phone: 66868978654, Email: pitipol@hotmail.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Anterior chamber reaction
Secondary outcome: rate of increased intraocular pressure over 21 mmHgChanges of anterior chamber reaction over time
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pitipol Choopong, MD, Phone: 66868978654, Email: pitipol@hotmail.com
Siriraj Hospital, Bangkok-Noi, Bangkok 10700, Thailand; Recruiting Pitipol Choopong, MD, Phone: 66868978654, Email: pitipol@hotmail.com Pitipol Choopong, MD, Principal Investigator
Additional Information
Starting date: May 2012
Last updated: March 31, 2015
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