Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
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

Exclusion Criteria

  • Texas Department of Corrections medical records - Under 18 years-of-age - First intravitreal injection experience of patient

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Touka K Banaee, MD
409-772-1011
tobanaee@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Touka Banaee, MD
(409)772-1011
tobanaee@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.