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Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

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ClinicalTrials.gov Identifier: NCT01801774
Recruitment Status : Unknown
Verified March 2015 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : March 1, 2013
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Inflammation Intraocular Pressure Drug: Subtenon 20-mg triamcinolone injection Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : May 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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 Name: Triamcinolone




Primary Outcome Measures :
  1. Anterior chamber reaction [ Time Frame: postoperative day 28 ]
    proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5


Secondary Outcome Measures :
  1. rate of increased intraocular pressure over 21 mmHg [ Time Frame: preoperative, postoperative day 1,7,14,28,90 ]
    rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer

  2. Changes of anterior chamber reaction over time [ Time Frame: preoperative, postoperative day1, 7, 14, 28, 90 ]
    repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801774


Contacts
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Contact: Pitipol Choopong, MD 66868978654 pitipol@hotmail.com

Locations
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Thailand
Siriraj Hospital Recruiting
Bangkok-Noi, Bangkok, Thailand, 10700
Contact: Pitipol Choopong, MD    66868978654    pitipol@hotmail.com   
Principal Investigator: Pitipol Choopong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Pitipol Choopong, MD Mahidol University
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01801774    
Other Study ID Numbers: Si234/2012
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Mahidol University:
post-operative inflammation
steroid
intraocular pressure
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action