Retinal Disease
Conditions
Keywords
diabetic retinopathy, age-related macular edema
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
Interventions
DEVICEintraocular injection guide
The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection
DEVICEstandard lid speculum
standard wire lid speculum
Sponsors
Maturi, Raj K., M.D., P.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 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). |
Countries
United States
Participant flow
Recruitment details
all subjects presenting for bilateral injection were offered the chance to participate in this clinical trail
Pre-assignment details
eyes were chosen for the novel guide or standard lid speculum using a randomizing table
Participants by arm
| Arm | Count |
|---|---|
| All Participants Only subjects needing bilateral ocular injections were included in the study. The total number of participants was 50 (100 eyes). Baseline characteristics were identical in both groups. One eye received the treatment with the injection guide while the fellow eye received the treatment with a standard lid speculum. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Visual Analogue Scale (VAS)
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).
Time frame: one time for about 30 sec or less
Population: Total number of subjects is 50 - however as the system here is designed for whole body count (not bilateral organs such as eyes), the total number will appear to be double of actual number of subjects.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intraocular Injection Guide | Visual Analogue Scale (VAS) | 14 mm on the VAS | Standard Deviation 6 |
| Standard Lid Speculum | Visual Analogue Scale (VAS) | 33 mm on the VAS | Standard Deviation 7 |