drugset / Trial / NCT05331664
Dropless Pars Plana Vitrectomy Study
RandomizedParallel-groupOpen-labelTreatment
Summary
To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.
Timeline
- Start
- 2022-07-25
- Primary completion
- 2026-07-25
- Completion
- 2027-01-30
Publications
- Background Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24.
- Background Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1.
- Background Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556.
- Background Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atropine | Other / unclassified | 1 % | Topical |
| Comparator | Moxifloxacin | Small molecule | 0.5 % | Topical |
| Comparator | Prednisolone | Other / unclassified | 1 % | Topical |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 40 mg/ml | Other |
| Comparator | Trimethoprim | Small molecule | — | Topical |