Cool vs Room-temperature Artificial Tears
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cooled artificial tear group Stored at 4 degree Celsius |
Drug: Refresh Plus Preservative-free Lubricant Eye Drops
Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
|
Active Comparator: Room temperature artificial tear group Stored at 25 degree Celsius |
Drug: Refresh Plus Preservative-free Lubricant Eye Drops
Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
|
Outcome Measures
Primary Outcome Measures
- The efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection ocular discomfort as measured by pain scale survey. [with 72 hours of the intervention]
The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.
Exclusion Criteria:
-
Inability or lack of willingness to participate in the study
-
Active ocular infection including infectious uveitis
-
First time receiving intravitreal injection
-
Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
-
Less than 18 years of age
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Iowa Hospitals & Clinics - Department of Ophthalmology | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- University of Iowa
Investigators
- Principal Investigator: Douglas Jin, MD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01.
- 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(2):CD009729. doi: 10.1002/14651858.CD009729.pub2.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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