Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2005-11-30
2013-05-31
Brief Summary
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The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.
Detailed Description
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This is a randomized, prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery.
Disease State:
The conventional treatment for clinically significant macular edema is focal laser photocoagulation. In some diabetic patients however, the cataract often impedes fundus visualization for optimal laser treatment. In these patients focal laser treatment is deferred until after cataract surgery.
Study aim:
The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery.
Hypothesis:
We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema, we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome.
Study Procedures:
After informed consent is obtained each patient will be placed, based on a randomization scheme, into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laser therapy
If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser
Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
Triamcinolone therapy
At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.
Triamcinolone acetonide
4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
Interventions
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Triamcinolone acetonide
4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
laser
Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pre-operative visual acuity 20/50 or worse
* pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.
Exclusion Criteria
* vitreomacular traction
* macular hole
18 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Robert E Leonard, MD
Role: PRINCIPAL_INVESTIGATOR
Dean A. McGee Eye Institute
Locations
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Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Countries
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Related Links
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Dean McGee Eye Institute
Other Identifiers
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2746
Identifier Type: -
Identifier Source: org_study_id