University of Texas Medical Branch
Galveston, Texas, 77555, United States
NCT Number: NCT05640895
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.
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Notify Me18 year–100 year
All sexes
Observational
Galveston, Texas, 77555, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal injections will be made at varying sites; patients will report on pain perception
Time frame: Immediately post-injection
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.
The University of Texas Medical Branch, Galveston
Other
The Effect of Entry Site Distance From Limbus on Perceived Pain During Intravitreal Injection of Anti-VEGF (Vascular Endothelial Growth Factor) Agents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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