Study of Two-step Anesthesia in Intravitreal Injection

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Procedure: topical anesthesia; Procedure: Two step anesthesia

• Registration Number: NCT03871062
• Lead Sponsor: Aier School of Ophthalmology, Central South University

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-08
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-09-11
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical anesthesia group	topical anesthesia	conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times
two step anesthesia group	Two step anesthesia	conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Surgeon's ease	During surgery	Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort

Trial Locations

Locations (1)

Shanghai Aier Eye Hospital; 🇨🇳 Shanghai, China