Triamcinolone vs. Laser for Diabetic Macular Edema
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 05/31/2017 |
| Pirmasis pateikimas: | 09/27/2005 |
| Numatytas registravimas pateiktas: | 09/27/2005 |
| Pirmas paskelbtas: | 09/29/2005 |
| Paskutinis atnaujinimas pateiktas: | 06/28/2017 |
| Paskutinis atnaujinimas paskelbtas: | 07/27/2017 |
| Pirmųjų rezultatų pateikimo data: | 04/09/2017 |
| Pirmojo QC rezultatų pateikimo data: | 06/28/2017 |
| Pirmųjų paskelbtų rezultatų data: | 07/27/2017 |
| Faktinė studijų pradžios data: | 10/31/2005 |
| Numatoma pirminio užbaigimo data: | 04/30/2013 |
| Numatoma studijų užbaigimo data: | 04/30/2013 |
Būklė ar liga
Intervencija / gydymas
Drug: Triamcinolone therapy
Procedure: Laser therapy
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Active Comparator: 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. | Procedure: Laser therapy Laser treatment 1 month after cataract surgery with option to repeat once if no improvement. |
| Active Comparator: 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. | Drug: Triamcinolone therapy 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. [3 years]
Antrinės rezultatų priemonės
1. Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. [3 years]
