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To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraocular injection guide | Experimental | novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye |
|
| standard lid speculum | Active Comparator | Standard wire eyelid speculum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraocular injection guide | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one time for about 30 sec or less |
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Inclusion Criteria:
Exclusion Criteria:
-Any condition or reason that precludes the subject's ability to comply with the study -
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| Name | Affiliation | Role |
|---|---|---|
| Raj K Maturi, MD | Raj K. Maturi, MD, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raj K Maturi MD PC | Indianapolis | Indiana | 46290 | United States |
eyes were chosen for the novel guide or standard lid speculum using a randomizing table
all subjects presenting for bilateral injection were offered the chance to participate in this clinical trail
| ID | Title | Description |
|---|---|---|
| FG000 | Intraocular Injection Guide | novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye intraocular 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 |
| FG001 | Standard Lid Speculum | Standard wire eyelid speculum standard lid speculum: standard wire lid speculum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Median | Standard Deviation | mm on the VAS | one time for about 30 sec or less | eyes | eyes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraocular Injection Guide | novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye intraocular 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 |
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This is a small one event study (about 10 min duration). The participant evaluates which speculum (used for about 30 sec or less) during the procedure provides better comfort. Thus, long term evaluation has not been peformed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj K Maturi MD | Raj K M | 3178171414 | maturi.md@midwesteye.com |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| standard lid speculum | Device | standard wire lid speculum |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard Lid Speculum | Standard wire eyelid speculum standard lid speculum: standard wire lid speculum |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Standard Lid Speculum | Standard wire eyelid speculum standard lid speculum: standard wire lid speculum | 0 | 50 | 0 | 50 | 0 | 50 |
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| D048909 |
| Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |