drugset / Trial / NCT03383328
Study for Optimizing Anti-inflammatory Prophylaxis
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.
Timeline
- Start
- 2018-02-01
- Primary completion
- 2019-12-18
- Completion
- 2019-12-18
Publications
- Erichsen JH, Holm LM, Forslund Jacobsen M, Forman JL, Kessel L. Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Oct 1;139(10):1062-1070. doi: 10.1001/jamaophthalmol.2021.2976.
- Erichsen JH, Forman JL, Holm LM, Kessel L. Effect of anti-inflammatory regimen on early postoperative inflammation after cataract surgery. J Cataract Refract Surg. 2021 Mar 1;47(3):323-330. doi: 10.1097/j.jcrs.0000000000000455.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 2 mg | Other |
| Comparator | Ketorolac Tromethamine | Small molecule | 5 mg/ml | Topical |
| Comparator | Prednisolone | Other / unclassified | 1 % | Topical |