Clinical trial NCT05640895: Intravitreal Injection Site and Perceived Pain
Official title: The Effect of Entry Site Distance From Limbus on Perceived Pain During Intravitreal Injection of Anti-VEGF (Vascular Endothelial Growth Factor) Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Intravitreal injection
Retinal diseases
Age-related macular degeneration
Diabetic retinopathy
Retinal vein occlusion
Limbus
Quadrants (regions) of the eye
Injection site
Pseudophakic/aphakic eyes
Phakic eyes
Pars plana
Ciliary body
Vitrectomy
Crystalline lens
Retina
Bevacizumab
Ranibizumab
Aflibercept
Diabetic macular edema
Anti-VEGF (Vascular Endothelial Growth Factor)
Vabysmo
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be from university eye clinics scheduled to undergo intravitreal injections

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual scale analogues for pain
timeFrame: Immediately post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Touka K Banaee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.