Triamcinolone vs. Laser for Diabetic Macular Edema (IVTA)

University of Oklahoma (OU)

Status: Completed

Conditions: DIABETIC MACULAR EDEMA

Treatments: Procedure: laser; Drug: Triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00229931

2746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Laser therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: laser

Triamcinolone therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Triamcinolone acetonide