Intravitreal Injection Site and Perceived Pain

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Intravitreal injection site


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intravitreal injection site|Intravitreal injections will be made at varying sites; patients will report on pain perception|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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