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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser therapy | Active Comparator | 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. |
|
| Triamcinolone therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone acetonide | Drug | 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Leonard, MD | Dean A. McGee Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
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| Label | URL |
|---|---|
| Dean McGee Eye Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. | Due to lack of follow up from patients, this outcome was not analyzed; data were not collected | Posted | 3 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous Hemorrhage | Eye disorders | Non-systematic Assessment |
Due to lack of patient follow up on this study, sufficient data was not available for analysis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert E. Leonard, II, MD | Dean McGee Eye Institute | 405-271-6307 | sonny-icks@dmei.org |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| laser | Procedure | Laser treatment 1 month after cataract surgery with option to repeat once if no improvement. |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
|
| Secondary | Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. | Data were not collected | Posted | 3 years |
|
|
| 2 |
| 6 |
| 1 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 1 | 5 |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient admitted to hospital for shortness of breath |
|
| Kidney Failure | Renal and urinary disorders | Non-systematic Assessment | Patient admitted to hospital for kidney failure |
|
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| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |