Study of Two-step Anesthesia in Intravitreal Injection

A Prospective, Randomised, Single-masked Comparison of Topical Anesthesia and Topical Combined Subconjunctival (Two-step) Anesthesia in Intravitreal Injection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03871062

Acronym

TAIVI

Enrollment

Registered

2019-03-12

Start date

2019-03-08

Completion date

2020-01-01

Last updated

2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Keywords

intravitreal injection, pain, anesthesia

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

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.

Interventions

PROCEDURETwo step anesthesia

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

PROCEDUREtopical anesthesia

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain scores	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

Secondary

Measure	Time frame	Description
Surgeon's ease	During surgery	Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort

Countries

China

Contacts

Primary ContactDong Lin

lindong_1219@126.com+86-13080707858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026