Anesthesia, LocalTAIVINCT03871062
Study of Two-step Anesthesia in Intravitreal Injection
A study testing Two step anesthesia and topical anesthesia in people with Anesthesia, Local, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) for intravitreal injection #TAIVI# vs topical anesthesia Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Two step anesthesia and topical anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2019to 1 Jan 2020
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neovascular age-related macular degeneration (wAMD); Pathologic myopia with choroidal neovascularisation (PM-CNV); Diabetic macular edema (DME); Retinal vein occlusion with macular edema (RVO-ME); Other diseases: uveitis with macular edema or choroidal neovascularisation.
Who cannot join
- Communication problems; Allergy to amide-type local anaesthetic agents; History of vitreoretinal surgery or orbital surgery; Orbital deformity; With episcleral adjunct surgery; Trauma; Keratitis; Conjunctivitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Aier Eye Hospital
Shanghai, 200336
Dong Lin, +86-13080707585, lindong_1219@126.com
About this study
Official title: A Prospective, Randomised, Single-masked Comparison of Topical Anesthesia and Topical Combined Subconjunctival (Two-step) Anesthesia in Intravitreal Injection
A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) for intravitreal injection #TAIVI# vs topical anesthesia
Read the detailed description
Purpose: Patient pain for intravitreal injection is evaluated between topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) and topical anesthesia.
Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients will be randomized divided into 2 groups and underwent intravitreal injection of antiangiogenic agents and steroids. Group1 uses two-step anesthesia , whereas Group 2 uses topical anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.
- Conditions
- Anesthesia, Local
- Being tested
- Two step anesthesia, topical anesthesia
- Keywords
- intravitreal injection, pain, anesthesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two step anesthesiaProcedure or surgery
conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection
topical anesthesiaProcedure or surgery
conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times
| Study group | Role | What they receive |
|---|---|---|
| topical anesthesia group | Active comparator | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times Receives: Procedure: topical anesthesia |
| two step anesthesia group | Experimental | conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection Receives: Procedure: Two step anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
5-point Visual Analogue Pain Scale (VAPS): Grade 1: No pain or discomfort; Grade 2: mild pain or discomfort; Grade 3: moderate pain or discomfort; Grade 4: severe pain or discomfort
Measured: During surgery
Secondary outcomes (1)
Surgeon's ease
Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start8 Mar 2019 (estimated)
- Primary completion11 Sep 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wensheng Li, Study director, Shanghai Aier Eye Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871062
- Sponsor's protocol ID
- SHIRB20190228
- Acronym
- TAIVI
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shiroma HF, Takaschima AKK, Farah ME, Hofling-Lima AL, de Luca Canto G, Benedetti RH, Rodrigues EB. Patient pain during intravitreal injections under topical anesthesia: a systematic review. Int J Retina Vitreous. 2017 Jul 3;3:23. doi: 10.1186/s40942-017-0076-9. eCollection 2017.
PubMed 28680703Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724.
PubMed 21102369Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15.
PubMed 29770638Nguyen NCI, Fabro F, Ambresin A, Ezziat S, Bergin C, Mazzocato C, Mantel I. Factors associated with pain during intravitreal injection of anti-vascular endothelial growth factor. Eye (Lond). 2018 Sep;32(9):1544-1546. doi: 10.1038/s41433-018-0126-z. Epub 2018 May 17. No abstract available.
PubMed 29769650Sanabria MR, Montero JA, Losada MV, Fernandez-Munoz M, Galindo A, Fernandez I, Coco RM, Sampedro A. Ocular pain after intravitreal injection. Curr Eye Res. 2013 Feb;38(2):278-82. doi: 10.3109/02713683.2012.758290. Epub 2013 Jan 18.
PubMed 23330822
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Single-masked Comparison of Topical Anesthesia and Topical Combined Subconjunctival (Two-step) Anesthesia in Intravitreal Injection
- ClinicalTrials.gov ID
- NCT03871062
- Acronym / sponsor ID
- TAIVI / SHIRB20190228
- Conditions
- Anesthesia, Local
- Keywords
- intravitreal injection, pain, anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 8 Mar 2019 (estimated)
- Primary completion
- 11 Sep 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 12 Mar 2019 (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.
A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) for intravitreal injection #TAIVI# vs topical anesthesia
Detailed description
Purpose: Patient pain for intravitreal injection is evaluated between topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) and topical anesthesia.
Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients will be randomized divided into 2 groups and underwent intravitreal injection of antiangiogenic agents and steroids. Group1 uses two-step anesthesia , whereas Group 2 uses topical anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical anesthesia group | Active comparator | Procedure: topical anesthesiaconjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times |
| two step anesthesia group | Experimental | Procedure: Two step anesthesiaconjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neovascular age-related macular degeneration (wAMD); Pathologic myopia with choroidal neovascularisation (PM-CNV); Diabetic macular edema (DME); Retinal vein occlusion with macular edema (RVO-ME); Other diseases: uveitis with macular edema or choroidal neovascularisation.
Key exclusion criteria (1 listed)
- Communication problems; Allergy to amide-type local anaesthetic agents; History of vitreoretinal surgery or orbital surgery; Orbital deformity; With episcleral adjunct surgery; Trauma; Keratitis; Conjunctivitis.
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 |
|---|---|---|
| Two step anesthesiaconjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection | Procedure or surgery | two step anesthesia group |
| topical anesthesiaconjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times | Procedure or surgery | topical anesthesia group |
Primary outcome
Pain scores
Time frame: During surgery
5-point Visual Analogue Pain Scale (VAPS): Grade 1: No pain or discomfort; Grade 2: mild pain or discomfort; Grade 3: moderate pain or discomfort; Grade 4: severe pain or discomfort
1 secondary outcome
Surgeon's ease
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 28680703Shiroma HF, Takaschima AKK, Farah ME, Hofling-Lima AL, de Luca Canto G, Benedetti RH, Rodrigues EB. Patient pain during intravitreal injections under topical anesthesia: a systematic review. Int J Retina Vitreous. 2017 Jul 3;3:23. doi: 10.1186/s40942-017-0076-9. eCollection 2017.
- Results publication: PubMed 21102369Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724.
- Results publication: PubMed 29770638Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15.
- Results publication: PubMed 29769650Nguyen NCI, Fabro F, Ambresin A, Ezziat S, Bergin C, Mazzocato C, Mantel I. Factors associated with pain during intravitreal injection of anti-vascular endothelial growth factor. Eye (Lond). 2018 Sep;32(9):1544-1546. doi: 10.1038/s41433-018-0126-z. Epub 2018 May 17. No abstract available.
- Results publication: PubMed 23330822Sanabria MR, Montero JA, Losada MV, Fernandez-Munoz M, Galindo A, Fernandez I, Coco RM, Sampedro A. Ocular pain after intravitreal injection. Curr Eye Res. 2013 Feb;38(2):278-82. doi: 10.3109/02713683.2012.758290. Epub 2013 Jan 18.
- Individual participant dataSharing planned: Undecided
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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.
Wensheng Li study director
Shanghai Aier Eye Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two step anesthesia and topical anesthesia in people with Anesthesia, Local, run by Aier School of Ophthalmology, Central South University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Lin (+86-13080707858, lindong_1219@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: During surgery). 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 NCT03871062, which also lists 5 linked publications.
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 19 Mar 2019.