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Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Primary Purpose

Inflammation, Intraocular Pressure

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Subtenon 20-mg triamcinolone injection
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring post-operative inflammation, steroid, intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Dexamethasone

Triamcinolone

Arm Description

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

Subtenon 20-mg Triamcinolone injection

Outcomes

Primary Outcome Measures

Anterior chamber reaction
proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5

Secondary Outcome Measures

rate of increased intraocular pressure over 21 mmHg
rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer
Changes of anterior chamber reaction over time
repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90

Full Information

First Posted
February 26, 2013
Last Updated
March 31, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01801774
Brief Title
Efficacy Comparison Study of Steroids to Control Post-operative Inflammation
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Intraocular Pressure
Keywords
post-operative inflammation, steroid, intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Placebo Comparator
Arm Description
Dexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days
Arm Title
Triamcinolone
Arm Type
Active Comparator
Arm Description
Subtenon 20-mg Triamcinolone injection
Intervention Type
Drug
Intervention Name(s)
Subtenon 20-mg triamcinolone injection
Other Intervention Name(s)
Triamcinolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Anterior chamber reaction
Description
proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5
Time Frame
postoperative day 28
Secondary Outcome Measure Information:
Title
rate of increased intraocular pressure over 21 mmHg
Description
rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer
Time Frame
preoperative, postoperative day 1,7,14,28,90
Title
Changes of anterior chamber reaction over time
Description
repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90
Time Frame
preoperative, postoperative day1, 7, 14, 28, 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pitipol Choopong, MD
Phone
66868978654
Email
pitipol@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pitipol Choopong, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok-Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pitipol Choopong, MD
Phone
66868978654
Email
pitipol@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pitipol Choopong, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

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