Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

NCT01801774 | Unknown Phase 4 DMC

• 1 other identifier: Si234/2012
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Intraocular Pressure

Keywords

post-operative inflammation; steroid; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• rate of increased intraocular pressure over 21 mmHg

  preoperative, postoperative day 1,7,14,28,90

• Changes of anterior chamber reaction over time

  preoperative, postoperative day1, 7, 14, 28, 90

Study Arms (2)

Dexamethasone

PLACEBO COMPARATOR

Dexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days

Drug: Placebo

Triamcinolone

ACTIVE COMPARATOR

Subtenon 20-mg Triamcinolone injection

Drug: Subtenon 20-mg triamcinolone injection

Interventions

Subtenon 20-mg triamcinolone injection DRUG

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.

Also known as: Triamcinolone

Triamcinolone

Placebo DRUG

Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus
• Pregnant and lactating women

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Pitipol Choopong, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pitipol Choopong, MD

CONTACT

66868978654; pitipol@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 1, 2013
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

TH (1)