Triamcinolone vs. Laser for Diabetic Macular Edema
Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: DIABETIC MACULAR EDEMA
Intervention: Triamcinolone acetonide (Drug); laser (Procedure)
Phase: N/A
Status: Completed
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s): Robert E Leonard, MD, Principal Investigator, Affiliation: Dean A. McGee Eye Institute
Summary
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 swelling in diabetic patients requiring cataract extraction as compared to
the conventional treatment of laser following cataract surgery.
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.
Clinical Details
Official title: The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Main outcome measures will be quantitative changes in OCT central thickness, visual acuity, and number of Snellen acuity lines gained/lost.
Secondary outcome: Rate of elevated intraocular pressures, retinal detachment, infection, and vitreous hemorrhage.
Detailed description:
Protocol Summary:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- visually significant cataracts
- pre-operative visual acuity 20/50 or worse
- pre-operative optical coherence tomography (OCT) showing at least 250 microns
central foveal thickness.
Exclusion Criteria:
- macular ischemia
- vitreomacular traction
- macular hole
Locations and Contacts
Dean A. McGee Eye Institute, Oklahoma City, Oklahoma 73104, United States
Additional Information
Dean McGee Eye Institute
Starting date: November 2005
Last updated: December 2, 2014
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