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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


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 mmHg

Changes 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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