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The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus.
In this pilot cross-over study, the investigators aim at exploring a factor not studied yet on the perception of pain during the injection procedure, and that is the distance of the entry site from the limbus.
Study population: Pseudophakic patients needing multiple intravitreal injections. In case of bilateral eligibility, one eye per patient will be included (randomly- based on a random chart).
Intervention: two injections per eye, will be included in the study. All steps of the technique will be similar between the two injections except for the entry site distance from the limbus, which will be 3.5 in one and 4.00 mm in the other. To prevent bias, the first injection entry distance will be randomly selected (based on a randomized chart).
The patient is blind to the entry distance, and a questionnaire with a visual analog pain scale will be given to the patient by a technician (to prevent any bias) to be filled after the injection. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection site | Procedure | Intravitreal injections will be made at varying sites; patients will report on pain perception |
| Measure | Description | Time Frame |
|---|---|---|
| Visual scale analogues for pain | Self-reported perception of pain according to analogue pain scale. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face. | Immediately post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be from university eye clinics scheduled to undergo intravitreal injections
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| Name | Affiliation | Role |
|---|---|---|
| Touka K Banaee, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19584648 | Result | Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01. | |
| 22657949 | Result | Gambrell J, Schaal S. Topical anesthesia for intravitreal injection. Expert Opin Drug Deliv. 2012 Jul;9(7):731-3. doi: 10.1517/17425247.2012.685156. Epub 2012 Jun 4. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D012164 | Retinal Diseases |
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D012170 | Retinal Vein Occlusion |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005128 | Eye Diseases |
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| 17621193 | Result | Tewari A, Shah GK, Dhalla MS, Blinder KJ. Surface anesthesia for office-based retinal procedures. Retina. 2007 Jul-Aug;27(6):804-5. doi: 10.1097/IAE.0b013e31804b4081. No abstract available. |
| 30202072 | Result | Karimi S, Mosavi SA, Jadidi K, Nikkhah H, Kheiri B. Which quadrant is less painful for intravitreal injection? A prospective study. Eye (Lond). 2019 Feb;33(2):304-312. doi: 10.1038/s41433-018-0208-y. Epub 2018 Sep 10. |
| 41430626 | Derived | Fan J, Guiseppi R, Digbeu B, Banaee T. Perception of pain during intravitreal injections: a clinical trial on the effect of entry site distance from the limbus on perceived pain. Int J Retina Vitreous. 2025 Dec 22;12(1):13. doi: 10.1186/s40942-025-00769-z. |
| D012162 | Retinal Degeneration |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D007905 | Lens Diseases |