Clinical trial NCT03871062: Study of Two-step Anesthesia in Intravitreal Injection
Official title: A Prospective, Randomised, Single-masked Comparison of Topical Anesthesia and Topical Combined Subconjunctival (Two-step) Anesthesia in Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: intravitreal injection
pain
anesthesia
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain scores
timeFrame: During surgery
Secondary outcomes:
measure: Surgeon's ease
timeFrame: During surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Aier Eye Hospital
Study officials:
affiliation: Shanghai Aier Eye Hosptial
name: Wensheng Li
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.