Ocular Surface Disease Clinical Trial
Official title:
Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for Reducing Surface Irritation Following Intravitreal Injection
| Verified date | April 2023 |
| Source | University of Iowa |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | July 6, 2022 |
| Est. primary completion date | July 1, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 105 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Iowa Hospitals & Clinics - Department of Ophthalmology | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| University of Iowa |
United States,
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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. — View Citation
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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. — View Citation
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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. — View Citation
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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. — View Citation
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* Note: There are 20 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | with 72 hours of the intervention |
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