Retinal DiseaseNCT02315170
Assessment of Novel Intraocular Injection Guide
A study testing intraocular injection guide and standard lid speculum in people with Retinal Disease, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- intraocular injection guide and standard lid speculum
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Any condition or reason that precludes the subject's ability to comply with the study -
Trial locations and contacts
1 site in 1 country.
About this study
To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.
Read the 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
- Conditions
- Retinal Disease
- Being tested
- intraocular injection guide, standard lid speculum
- Keywords
- diabetic retinopathy, age-related macular edema
- Medical subject headings
- Retinal Diseases, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular injection guideDevice
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 speculumDevice
standard wire lid speculum
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: intraocular injection guide |
| standard lid speculum | Active comparator | Standard wire eyelid speculum Receives: Device: standard lid speculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one time for about 30 sec or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Responsible party
- Principal investigator, Raj Maturi, Maturi, Raj K., M.D., P.C.
- Investigators
- Raj K Maturi, MD, Principal investigator, Raj K. Maturi, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315170
- Sponsor's protocol ID
- rkm006
- Status last verified
- May 2021
- First submitted
- 9 Dec 2014
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Intraocular Injection Guide
- ClinicalTrials.gov ID
- NCT02315170
- Acronym / sponsor ID
- rkm006
- Conditions
- Retinal Disease
- Keywords
- diabetic retinopathy, age-related macular edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraocular injection guide | Experimental | Device: intraocular injection guidenovel 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 | Device: standard lid speculumStandard wire eyelid speculum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Any condition or reason that precludes the subject's ability to comply with the study -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraocular injection guideThe 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 | Device | intraocular injection guide |
| standard lid speculumstandard wire lid speculum | Device | standard lid speculum |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj K Maturi, MD principal investigator
Raj K. Maturi, MD, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular injection guide and standard lid speculum in people with Retinal Disease, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: one time for about 30 sec or less). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.