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| Name | Class |
|---|---|
| Vistar Eye Center | OTHER |
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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.
Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center 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 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol | Experimental | 1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm. |
|
| Artificial tears | Placebo Comparator | 1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel [Lotemax] | Drug | Loteprednol (ophthalmic corticosteroid) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 15°-25°C (59°-77°F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Intravitreal Injection Pain | 11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain) | 2-hour Post-Intravitreal Injection |
| Post-Intravitreal Injection Pain | 11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain) | 1-day Post-Intravitreal Injection |
| Post-Intravitreal Injection Pain | 11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain) | 1-week Post-Intravitreal Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Medication Use | Pill count | 2-hour Post-Intravitreal Injection |
| Analgesic Medication Use | Pill count | 1-day Post-Intravitreal Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishak John, MD | Vistar Eye Center | Principal Investigator |
| Romulo Albuquerque, M.D., Ph.D. | Vistar Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vistar Eye Center | Roanoke | Virginia | 24019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22794258 | 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. | |
| 22707339 | 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. |
| Label | URL |
|---|---|
| Lotemax Information | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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Double-blinded placebo-controlled design
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The study design is a double-blinded placebo-controlled experiment, as the patient and the investigator recording the pain scores will not know which treatment arm the patient is assigned to (negative control or experimental group).
|
| Refresh Lubricant Eye Drops [Artificial Tears] | Other | REFRESH® Brand Lubricant Eye Drops are artificial tears. In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection. |
|
|
| Analgesic Medication Use | Pill count | 1-week Post-Intravitreal Injection |
| Artificial Tear Use | Artificial Tear Drop Count | 2-hour Post-Intravitreal Injection |
| Artificial Tear Use | Artificial Tear Drop Count | 1-day Post-Intravitreal Injection |
| Artificial Tear Use | Artificial Tear Drop Count | 1-week Post-Intravitreal Injection |
| 22091473 | 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/ |
| 18090893 | 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. |
| 11150074 | 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. |
| 31447544 | 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. |
| 29393226 | 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. |
| 27182271 | 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. |
| 31221565 | 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. |
| 32381252 | 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. |
| 20689798 | Background | Karia N. Retinal vein occlusion: pathophysiology and treatment options. Clin Ophthalmol. 2010 Jul 30;4:809-16. doi: 10.2147/opth.s7631. |
| 27366700 | 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. |
| 32199867 | 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. |
| 22562296 | 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. |
| 29770638 | 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. |
| 27789936 | 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. |
| 28781409 | 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. |
| 16000093 | 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. |
| 31305506 | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |