Triamcinolone vs. Laser for Diabetic Macular Edema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema

Conditions
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DIABETIC MACULAR EDEMA

Intervention / Treatment
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* Drug: Triamcinolone acetonide
* Procedure: laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser therapy<br>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. | Procedure: laser<br>* Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.<br>* Other names: focal laser photocoagulation;|
| Active Comparator: Triamcinolone therapy<br>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. | Drug: Triamcinolone acetonide<br>* 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response<br>* Other names: Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CATARACT EXTRACTION, MACULAR EDEMA, DIABETES, FOCAL LASER, TRIAMCINOLONE