N/A
Completed N=11
Triamcinolone vs. Laser for Diabetic Macular Edema
Source: ClinicalTrials.gov NCT00229931 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jul 2017
Primary outcomePrimary: Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. |
— | — |
| SECONDARY Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00229931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.