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Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.
Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooled artificial tear group | Experimental | Stored at 4 degree Celsius |
|
| Room temperature artificial tear group | Active Comparator | Stored at 25 degree Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refresh Plus Preservative-free Lubricant Eye Drops | Drug | Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. | The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain | with 72 hours of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Jin, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics - Department of Ophthalmology | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19584648 | Background | Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01. | |
| 31923477 | Background | Patel SN, Gangaputra S, Sternberg P Jr, Kim SJ. Prophylaxis measures for postinjection endophthalmitis. Surv Ophthalmol. 2020 Jul-Aug;65(4):408-420. doi: 10.1016/j.survophthal.2019.12.005. Epub 2020 Jan 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cooled Artificial Tear Group | Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius |
| FG001 | Room Temperature Artificial Tear Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2022 | Jan 2, 2025 |
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| 28984794 | Background | Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437. |
| 32995498 | Background | Swift W, Bair JA, Chen W, Li M, Lie S, Li D, Yang M, Shatos MA, Hodges RR, Kolko M, Utheim TP, Scott W, Dartt DA. Povidone iodine treatment is deleterious to human ocular surface conjunctival cells in culture. BMJ Open Ophthalmol. 2020 Sep 16;5(1):e000545. doi: 10.1136/bmjophth-2020-000545. eCollection 2020. |
| 28166657 | Background | Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul Toxicol. 2017 Dec;36(4):343-346. doi: 10.1080/15569527.2017.1291665. Epub 2017 Feb 28. |
| 28860698 | Background | Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and proposed management strategies. Clin Ophthalmol. 2017 Aug 16;11:1491-1497. doi: 10.2147/OPTH.S136500. eCollection 2017. |
| 31237739 | Background | Dohlman TH, Lertsuwanroj B, D'Amico DJ, Ciralsky JB, Kiss S. Evaluation of signs and symptoms of ocular surface disease after intravitreal injection. Acta Ophthalmol. 2019 Dec;97(8):e1154-e1156. doi: 10.1111/aos.14146. Epub 2019 Jun 25. No abstract available. |
| 26215781 | Background | Segal O, Segal-Trivitz Y, Nemet AY, Cohen P, Geffen N, Mimouni M. Anxiety levels and perceived pain intensity during intravitreal injections. Acta Ophthalmol. 2016 Mar;94(2):203-4. doi: 10.1111/aos.12802. Epub 2015 Jul 28. No abstract available. |
| 31133544 | Background | Chaturvedi R, Wannamaker KW, Riviere PJ, Khanani AM, Wykoff CC, Chao DL. Real-World Trends in Intravitreal Injection Practices among American Retina Specialists. Ophthalmol Retina. 2019 Aug;3(8):656-662. doi: 10.1016/j.oret.2019.03.023. Epub 2019 Apr 4. |
| 25489719 | Background | Avery RL, Bakri SJ, Blumenkranz MS, Brucker AJ, Cunningham ET Jr, D'Amico DJ, Dugel PU, Flynn HW Jr, Freund KB, Haller JA, Jumper JM, Liebmann JM, McCannel CA, Mieler WF, Ta CN, Williams GA. Intravitreal injection technique and monitoring: updated guidelines of an expert panel. Retina. 2014 Dec;34 Suppl 12:S1-S18. doi: 10.1097/IAE.0000000000000399. |
| 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. |
| 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. |
| 11994027 | Background | Gaynes BI, Fiscella R. Topical nonsteroidal anti-inflammatory drugs for ophthalmic use: a safety review. Drug Saf. 2002;25(4):233-50. doi: 10.2165/00002018-200225040-00002. |
| 9395871 | Background | Fujishima H, Yagi Y, Shimazaki J, Tsubota K. Effects of artificial tear temperature on corneal sensation and subjective comfort. Cornea. 1997 Nov;16(6):630-4. |
| 25907208 | Background | Hu Youwei J, Chang B. Effect of cooling proparacaine 0.5% eye drops on patient's comfort during instillation. Eye (Lond). 2015 Aug;29(8):1112-3. doi: 10.1038/eye.2015.59. Epub 2015 Apr 24. No abstract available. |
| 33059077 | Background | Ramos MS, Xu LT, Singuri S, Castillo Tafur JC, Arepalli S, Ehlers JP, Kaiser PK, Singh RP, Rachitskaya AV, Srivastava SK, Sears JE, Schachat AP, Babiuch AS, Sharma S, Martin DF, Lowder CY, Singh AD, Yuan A, Nowacki AS. Patient-Reported Complications after Intravitreal Injection and Their Predictive Factors. Ophthalmol Retina. 2021 Jul;5(7):625-632. doi: 10.1016/j.oret.2020.09.024. Epub 2020 Oct 12. |
| 25686388 | Background | Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015 Jan 30;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071. |
| 29457271 | Background | Bitton E, Crncich V, Brunet N. Does the temperature of an artificial tear affect its comfort? Clin Exp Optom. 2018 Sep;101(5):641-647. doi: 10.1111/cxo.12664. Epub 2018 Feb 18. |
| 26905373 | Background | Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database Syst Rev. 2016 Feb 23;2:CD009729. doi: 10.1002/14651858.CD009729.pub2. |
| 31447543 | Background | Walsh K, Jones L. The use of preservatives in dry eye drops. Clin Ophthalmol. 2019 Aug 1;13:1409-1425. doi: 10.2147/OPTH.S211611. eCollection 2019. |
Stored at 25 degree Celsius
Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cooled Artificial Tear Group | Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius |
| BG001 | Room Temperature Artificial Tear Group | Stored at 25 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. | The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain | Posted | Mean | Standard Deviation | score on a scale | with 72 hours of the intervention |
|
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The specific period time over which adverse event data were collected was 4 months, which was the entire duration of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cooled Artificial Tear Group | Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius | 0 | 48 | 0 | 48 | 0 | 48 |
| EG001 | Room Temperature Artificial Tear Group | Stored at 25 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 25 degree Celsius | 0 | 61 | 0 | 61 | 0 | 61 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Jin, MD | University of Iowa | 319-356-3185 | Douglas-Jin@uiowa.edu |
| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2022 | Feb 24, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D008269 | Macular Edema |
| D058447 | Eye Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|