Trial Outcomes & Findings for Assessment of Novel Intraocular Injection Guide (NCT NCT02315170)
NCT ID: NCT02315170
Last Updated: 2021-05-05
Results Overview
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).
COMPLETED
NA
50 participants
one time for about 30 sec or less
2021-05-05
Participant Flow
all subjects presenting for bilateral injection were offered the chance to participate in this clinical trail
eyes were chosen for the novel guide or standard lid speculum using a randomizing table
Unit of analysis: eyes
Participant milestones
| Measure |
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
|
Standard Lid Speculum
Standard wire eyelid speculum
standard lid speculum: standard wire lid speculum
|
|---|---|---|
|
Overall Study
STARTED
|
50 50
|
50 50
|
|
Overall Study
COMPLETED
|
50 50
|
50 50
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Novel Intraocular Injection Guide
Baseline characteristics by cohort
| Measure |
All Participants
n=50 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one time for about 30 sec or lessPopulation: 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.
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).
Outcome measures
| Measure |
Intraocular Injection Guide
n=50 eyes
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
|
Standard Lid Speculum
n=50 eyes
Standard wire eyelid speculum
standard lid speculum: standard wire lid speculum
|
|---|---|---|
|
Visual Analogue Scale (VAS)
|
14 mm on the VAS
Standard Deviation 6
|
33 mm on the VAS
Standard Deviation 7
|
Adverse Events
Intraocular Injection Guide
Standard Lid Speculum
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place