Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Intraocular Pressure
• Intervention / Treatment: Drug: Placebo; Drug: Subtenon 20-mg triamcinolone injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pitipol Choopong, MD; Phone Number: 66868978654; Email: pitipol@hotmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok-Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Pitipol Choopong, MD; Phone Number: 66868978654; Email: pitipol@hotmail.com
      • Principal Investigator: Pitipol Choopong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Pitipol Choopong, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: intraocular pressure; steroid; post-operative inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: Si234/2012