The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
Summary
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.
Timeline
- Start
- 2022-12-22
- Primary completion
- 2024-05-01
- Completion
- 2025-05-01
Publications
- Background Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
- Background Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
- Background Chou R, McDonagh MS, Nakamoto E, Griffin J. Analgesics for Osteoarthritis: An Update of the 2006 Comparative Effectiveness Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Oct. Report No.: 11(12)-EHC076-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK65646/
- Background DeCroos FC, Afshari NA. Perioperative antibiotics and anti-inflammatory agents in cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):22-6. doi: 10.1097/ICU.0b013e3282f30577.
- Background El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2001 Feb;12(1):4-8. doi: 10.1097/00055735-200102000-00002.
- Background Fong R, Cavet ME, DeCory HH, Vittitow JL. Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies. Clin Ophthalmol. 2019 Aug 1;13:1427-1438. doi: 10.2147/OPTH.S210597. eCollection 2019.
- Background Grzybowski A, Told R, Sacu S, Bandello F, Moisseiev E, Loewenstein A, Schmidt-Erfurth U; Euretina Board. 2018 Update on Intravitreal Injections: Euretina Expert Consensus Recommendations. Ophthalmologica. 2018;239(4):181-193. doi: 10.1159/000486145. Epub 2018 Feb 1.
- Background Gundogan FC, Yolcu U, Akay F, Ilhan A, Ozge G, Uzun S. Diabetic Macular Edema. Pak J Med Sci. 2016 Mar-Apr;32(2):505-10. doi: 10.12669/pjms.322.8496.
- Background Kaplan RI, Drinkwater OJ, Lee RH, Chod RB, Barash A, Giovinazzo JV, Gologorsky D, Jansen ME, Rosen RB, Gentile RC. Pain Control after Intravitreal Injection Using Topical Nepafenac 0.3% or Pressure Patching: A Randomized, Placebo-Controlled Trial. Ophthalmol Retina. 2019 Oct;3(10):860-866. doi: 10.1016/j.oret.2019.04.022. Epub 2019 Apr 26.
- Background Kaplan RI, Rosen RB, Gentile RC. Optimizing the Patient Experience and Satisfaction: The Role of Topical NSAIDs with Intravitreal Injections. Ophthalmol Retina. 2020 May;4(5):459-460. doi: 10.1016/j.oret.2020.03.004. No abstract available.
- Background Karia N. Retinal vein occlusion: pathophysiology and treatment options. Clin Ophthalmol. 2010 Jul 30;4:809-16. doi: 10.2147/opth.s7631.
- Background Oztas Z, Akkin C, Afrashi F, Nalcaci S. The short-needle intravitreal injection technique. Int J Ophthalmol. 2016 Jun 18;9(6):929-30. doi: 10.18240/ijo.2016.06.24. eCollection 2016. No abstract available.
- Background Popovic MM, Muni RH, Nichani P, Kertes PJ. Topical Nonsteroidal Anti-inflammatory Drugs for Pain Resulting from Intravitreal Injections: A Meta-Analysis. Ophthalmol Retina. 2020 May;4(5):461-470. doi: 10.1016/j.oret.2020.01.024. Epub 2020 Feb 13.
- Background Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.
- Background Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15.
- Background Tan HY, Agarwal A, Lee CS, Chhablani J, Gupta V, Khatri M, Nirmal J, Pavesio C, Agrawal R. Management of noninfectious posterior uveitis with intravitreal drug therapy. Clin Ophthalmol. 2016 Oct 13;10:1983-2020. doi: 10.2147/OPTH.S89341. eCollection 2016.
- Background Toslak D, Thapa D, Chen Y, Erol MK, Paul Chan RV, Yao X. Wide-field fundus imaging with trans-palpebral illumination. Proc SPIE Int Soc Opt Eng. 2017 Jan 28;10045:100451X. doi: 10.1117/12.2252491. Epub 2017 Feb 8.
- Background Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Background Yahalomi T, Hecht I, Lagstein O, Nemet A, Pe'er L, Hadad F, Keren-Yaar A, Kassem R, Burgansky-Eliash Z, Bar A, Achiron A. REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial. Retina. 2020 Jul;40(7):1434-1438. doi: 10.1097/IAE.0000000000002608.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loteprednol Etabonate | Other / unclassified | — | Other |