Neovascular Age-related Macular DegenerationTIVINCT04455399
Time Efficiency Comparison of Two IntraVitreal Injection Techniques
A study testing Intravitreal injection guide (Malosa) and Dual Blade Eyelid Speculum in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
Trial summary
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion With Macular Edema
- What is being tested?
- Intravitreal injection guide (Malosa) and Dual Blade Eyelid Speculum
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePhilippines
- Study dates
- 9 Nov 2020to 9 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Who cannot join
- History of extraocular or intraocular infection within 3 months of the scheduled IVI date
- Scleral thinning
- History of previous glaucoma surgery
- History of pars plana vitrectomy
- Hypersensitivity to the IVI drug, proparacaine or povidone iodine
- Inability to understand the informed consent form
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Peregrine Eye and Laser Instittute
Makati City, MM, 1209
About this study
Official title: Time Efficiency Comparison of Two Intravitreal Injection Techniques
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
Read the detailed description
Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral thinning, history of previous glaucoma surgery, history of pars plana vitrectomy, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.
The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.
- Conditions
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion With Macular Edema, Uveitic Macular Edema, Choroidal Neovascularization
- Being tested
- Intravitreal injection guide (Malosa), Dual Blade Eyelid Speculum
- Keywords
- intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF
- Medical subject headings
- Choroidal Neovascularization, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection guide (Malosa)Device
Also called Malosa intravitreal injection guide
A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion
Dual Blade Eyelid SpeculumDevice
A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal injection guide | Other | Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye Receives: Device: Intravitreal injection guide (Malosa) |
| Dual blade eyelid speculum | Other | Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus Receives: Device: Dual Blade Eyelid Speculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intravitreal injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
Measured: At time of injection procedure
Secondary outcomes (2)
Adverse event rate
Frequency of adverse events and serious adverse events after intravitreal injection
Measured: Immediately and up to 1 month after the intravitreal injection procedure
Patient preference for IVI technique
Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum
Measured: Immediately post injection using single-blade speculum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start9 Nov 2020
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Eye and Laser Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harvey Siy Uy, Peregrine Eye and Laser Institute
- Investigators
- Harvey S Uy, MD, Principal investigator, Peregrine Eye and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455399
- Sponsor's protocol ID
- 20200102
- Acronym
- TIVI
- Status last verified
- Apr 2021
- First submitted
- 28 Jun 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uy HS, Artiaga JCM. Comparison of Two Different Intravitreal Injection Techniques. Clin Ophthalmol. 2021 Jun 8;15:2383-2389. doi: 10.2147/OPTH.S309501. eCollection 2021.
PubMed 34135566
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Efficiency Comparison of Two Intravitreal Injection Techniques
- ClinicalTrials.gov ID
- NCT04455399
- Acronym / sponsor ID
- TIVI / 20200102
- Conditions
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion With Macular Edema, Uveitic Macular Edema, Choroidal Neovascularization
- Keywords
- intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peregrine Eye and Laser InstituteUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
Detailed description
Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral thinning, history of previous glaucoma surgery, history of pars plana vitrectomy, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.
The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
| Arm | Type | Receives |
|---|---|---|
| Intravitreal injection guide | Other | Device: Intravitreal injection guide (Malosa)Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye |
| Dual blade eyelid speculum | Other | Device: Dual Blade Eyelid SpeculumDual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Key exclusion criteria (6 listed)
- History of extraocular or intraocular infection within 3 months of the scheduled IVI date
- Scleral thinning
- History of previous glaucoma surgery
- History of pars plana vitrectomy
- Hypersensitivity to the IVI drug, proparacaine or povidone iodine
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 |
|---|---|---|
| Intravitreal injection guide (Malosa)Also: Malosa intravitreal injection guideA single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion | Device | Intravitreal injection guide |
| Dual Blade Eyelid SpeculumA conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site. | Device | Dual blade eyelid speculum |
Primary outcome
Duration of intravitreal injection procedure
Time frame: At time of injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
2 secondary outcomes
Adverse event rate
Time frame: Immediately and up to 1 month after the intravitreal injection procedure
Patient preference for IVI technique
Time frame: Immediately post injection using single-blade speculum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 34135566Uy HS, Artiaga JCM. Comparison of Two Different Intravitreal Injection Techniques. Clin Ophthalmol. 2021 Jun 8;15:2383-2389. doi: 10.2147/OPTH.S309501. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Harvey S Uy, MD principal investigator
Peregrine Eye and Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal injection guide (Malosa) and Dual Blade Eyelid Speculum in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Peregrine Eye and Laser Institute at 1 site in Philippines.
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 1 inclusion and 6 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 27 Apr 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 Philippines. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of intravitreal injection procedure (time frame: At time of injection procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455399, which also lists 1 linked publication.
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 27 Apr 2021; AzTrials last refreshed its copy on 29 Oct 2026.