NCT03871062

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 10, 2019

Last Update Submit

March 17, 2019

Conditions

Anesthesia, Local

Keywords

intravitreal injectionpainanesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

    During surgery

Secondary Outcomes (1)

  • Surgeon's ease

    During surgery

Study Arms (2)

topical anesthesia group

ACTIVE COMPARATOR

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times

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

Procedure: Two step anesthesia

Interventions

Two step anesthesiaPROCEDURE

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection

two step anesthesia group
topical anesthesiaPROCEDURE

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times

topical anesthesia group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Aier Eye Hospital

Shanghai, 200336, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28680703RESULT

  • Blaha 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.

    PMID: 21102369RESULT

  • Shin 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.

    PMID: 29770638RESULT

  • Nguyen 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.

    PMID: 29769650RESULT

  • Sanabria 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.

    PMID: 23330822RESULT

MeSH Terms

Conditions

Pain

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Wensheng Li

    Shanghai Aier Eye Hosptial

    STUDY DIRECTOR

Central Study Contacts

Dong Lin

CONTACT

+86-13080707858lindong_1219@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 12, 2019

Study Start

March 8, 2019

Primary Completion

September 11, 2019

Study Completion

January 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

CN(1)