Clinical Trial: Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery (Japan)

Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059769) titled 'Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery' on Nov. 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kyorin University School of Medicine

Condition: Condition - Cases Indicated for Simultaneous Cataract and Vitrectomy Surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to determine whether Tenon's capsule anesthesia using the new 25G sub-Tenon injection needle enables stable pain control throughout surgery. Conventional Tenon's capsule anesthesia needles had design limitations, but this product eliminates the need for conjunctival incision, promising reduced complications and improved operability. This research provides insights into its anesthetic efficacy and safety. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - After cataract surgery under topical anesthesia, Tenon's capsule anesthesia (2% lidocaine, 3 mL) is administered, followed by 25-gauge vitrectomy. The patient is evaluated for pain, ocular motility, eyelid movement, and the presence of anesthesia-related complications.

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients aged 40 years or older scheduled for simultaneous cataract and vitrectomy surgery Patients who have provided written consent Key exclusion criteria - Patients with ocular motor disorders Proliferative disease with proliferative membranes extending beyond two quadrants Hypersensitivity to local anesthetics Patients with a history of surgery at the same site Patients unable to verbally report NRS scores Target Size - 35

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 13 Day Date of IRB - 2025 Year 11 Month 13 Day Anticipated trial start date - 2025 Year 11 Month 13 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068347

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