drugset / Trial / NCT05413330
Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
RandomizedParallel-groupSingle-blindPrevention
Summary
The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. The investigators will categorize the participants into two groups: the case group who will receive the injection at the end of the surgery, and the control group who will have routine cataract surgery with no extra injections.
Timeline
- Start
- 2020-09-12
- Primary completion
- 2022-01-05
- Completion
- 2022-03-29
Publications
- Background Kim SY, Yang J, Lee YC, Park YH. Effect of a single intraoperative sub-Tenon injection of triamcinolone acetonide on the progression of diabetic retinopathy and visual outcomes after cataract surgery. J Cataract Refract Surg. 2008 May;34(5):823-6. doi: 10.1016/j.jcrs.2008.01.018.
- Background Chung J, Kim MY, Kim HS, Yoo JS, Lee YC. Effect of cataract surgery on the progression of diabetic retinopathy. J Cataract Refract Surg. 2002 Apr;28(4):626-30. doi: 10.1016/s0886-3350(01)01142-7.
- Background Lundstrom M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery. J Cataract Refract Surg. 2013 May;39(5):673-9. doi: 10.1016/j.jcrs.2012.11.026. Epub 2013 Mar 14.
- Background Simons RWP, Wielders LHP, Nuijts RMMA, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Dirksen CD; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6. J Cataract Refract Surg. 2022 May 1;48(5):555-563. doi: 10.1097/j.jcrs.0000000000000785.
- Background Mittra RA, Borrillo JL, Dev S, Mieler WF, Koenig SB. Retinopathy progression and visual outcomes after phacoemulsification in patients with diabetes mellitus. Arch Ophthalmol. 2000 Jul;118(7):912-7.
- Background Mentes J, Erakgun T, Afrashi F, Kerci G. Incidence of cystoid macular edema after uncomplicated phacoemulsification. Ophthalmologica. 2003 Nov-Dec;217(6):408-12. doi: 10.1159/000073070.
- Background Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.
- Background Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.
- Background Eriksson U, Alm A, Bjarnhall G, Granstam E, Matsson AW. Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):349-59. doi: 10.1007/s00417-010-1484-9. Epub 2010 Sep 9.
- Background Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Findl O, Murta JCN, Goslings WRO, Tassignon MJ, Joosse MV, Henry YP, Rulo AHF, Guell JL, Amon M, Kohnen T, Nuijts RMMA; ESCRS PREMED Study Group. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029.
- Zaher Addeen S, Shaddoud I. Combined phacoemulsification surgery and intravitreal triamcinolone injection versus stand-alone surgery in patients with type 2 diabetes: a prospective randomized trial. BMC Ophthalmol. 2022 Nov 19;22(1):445. doi: 10.1186/s12886-022-02676-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamcinolone Acetonide | Other / unclassified | 4 mg | Intravitreal |