Retinal Diseases
Conditions
Brief summary
Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach
Interventions
None listed
Sponsors
Medical College of Wisconsin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age 18 years or older who undergo intravitreal injection for clinical indications.
Exclusion criteria
* Patients under the age of 18 years * Patients unable to give informed consent * Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection * Disorders that preclude the ability to assess for complications of intravitreal injection * Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus * Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity associated with instrument type used for holding eyelids open during intravitreal injection | Within 15 minutes of injection procedure | A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural complications associated with instrument use during intravitreal injection procedure | Within 15 minutes of injection procedure | A questionnaire that queries about procedural complications will be completed by the treating physician. |
Countries
United States
Outcome results
None listed