Study of Two-step Anesthesia in Intravitreal Injection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Procedure: Two step anesthesia
* Procedure: topical anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical anesthesia group<br>conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times | Procedure: topical anesthesia<br>* conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times<br>|
| Experimental: two step anesthesia group<br>conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection | Procedure: Two step anesthesia<br>* conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravitreal injection, pain, anesthesia