Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01801774
• Other study ID #: Si234/2012
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2013
• Last updated: March 31, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Mahidol University
• Contact: Pitipol Choopong, MD
• Phone: 66868978654
• Email: pitipol[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Intraocular Pressure

Intervention

Drug:
• Subtenon 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.
• Placebo

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok-Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber reaction	proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5	postoperative day 28	No
Secondary	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	Yes
Secondary	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	No