Assessment of Novel Intraocular Injection Guide
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinal Disease
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.
Detailed Description
This study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. The hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. The results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections
Investigators
Raj Maturi
President
Maturi, Raj K., M.D., P.C.
Eligibility Criteria
Inclusion Criteria
- •Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
- •Injections in both eyes must be given on the same day
- •Male or female age 18 years or older
Exclusion Criteria
- •Any condition or reason that precludes the subject's ability to comply with the study -
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: one time for about 30 sec or less
The VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The scale scores range from 0mm (no pain) to 100mm (very severe pain). The patient marks on the line the point that they feel represents their perception of their current state (no pain to very severe pain).