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Triamcinolone Vs. Laser for Diabetic Macular Edema
This study is not yet open for participant recruitment.
Verified by Dean A. McGee Eye Institute, September 2005
First Received: September 28, 2005   No Changes Posted
Sponsored by: Dean A. McGee Eye Institute
Information provided by: Dean A. McGee Eye Institute
ClinicalTrials.gov Identifier: NCT00229931
  Purpose

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 6 visits over 1 year. Visits will occur at screening, surgery, 1, 3, 6, and 12 months post surgery.


Condition Intervention
Diabetic Macular Edema
Drug: Triamcinolone acetonide
Procedure: Focal laser

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Cataract Edema Surgery
Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema

Further study details as provided by Dean A. McGee Eye Institute:

Primary Outcome Measures:
  • Main outcome measures will be quantitative changes in OCT central thickness, visual acuity, and number of Snellen acuity lines gained/lost.

Secondary Outcome Measures:
  • Rate of elevated intraocular pressures, retinal detachment, infection, and vitreous hemorrhage.

Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Study Completion Date: October 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229931

Contacts
Contact: Lisa M Ogilbee, BS, CCRC 405-271-6307 ext 51163 lisa-ogilbee@dmei.org
Contact: Connie J Dwiggins, COA 405-271-6307 ext 51167 connie-dwiggins@dmei.org

Locations
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Dean A. McGee Eye Institute
Investigators
Principal Investigator: Robert E Leonard, MD Dean A. McGee Eye Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: IVTA - DME
Study First Received: September 28, 2005
Last Updated: September 28, 2005
ClinicalTrials.gov Identifier: NCT00229931     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Dean A. McGee Eye Institute:
CATARACT EXTRACTION
MACULAR EDEMA
DIABETES
FOCAL LASER
TRIAMCINOLONE

Study placed in the following topic categories:
Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate
Immunosuppressive Agents
Hormones
Glucocorticoids
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Cataract
Triamcinolone
Retinal Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Enzyme Inhibitors
Triamcinolone diacetate
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009