Intravitreal Injection Site and Perceived Pain

Pain Clinical Trial

Official title:

The Effect of Entry Site Distance From Limbus on Perceived Pain During Intravitreal Injection of Anti-VEGF (Vascular Endothelial Growth Factor) Agents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640895
• Other study ID #: 22-0228
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Touka Banaee, MD
• Phone: (409)772-1011
• Email: tobanaee[@]utmb.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 18 -100 years

• Diagnosis of diabetic macular edema, age related macular degeneration, or retinal vein occlusion

• Treated with bevacizumab, ranibizumab, aflibercept

• The need for at least two intravitreal injections

• Pseudophakia

Exclusion Criteria:

• Texas Department of Corrections medical records

• Under 18 years-of-age

• First intravitreal injection experience of patient

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Intravitreal injection site
Intravitreal injections will be made at varying sites; patients will report on pain perception

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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