Intravitreal Injection Site and Perceived Pain

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Recruiting

CT.gov ID

NCT05640895

Collaborator

(none)

Enrollment

Location

13.1

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Intravitreal injection site

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Dec 18, 2023

Anticipated Study Completion Date :

Dec 18, 2023

Outcome Measures

Primary Outcome Measures

Visual scale analogues for pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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