Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries

This study aims to study the safety and efficacy of using an 18 mm short vitrectomy probe for pediatric vitreoretinal surgeries and to investigate the surgeon's comfort and reliability of using the shorter probe.

Study Overview

• Status: Recruiting
• Conditions: Retinal Vascular Disorder; Retinal Disease; Retinopathy of Prematurity Both Eyes; Vitreous Disorder; Coats Disease; Familial Exudative Vitreoretinopathies; Persistent Fetal Vasculature; Vitreous Anomalies; Coats Retinopathy
• Intervention / Treatment: Device: Pars plana vitrectomy with a 18 mm short vitrector

Detailed Description

With advancements in sutureless vitrectomy, more and more pediatric disease entities can be successfully coped with intraocular surgeries and with fewer complications. However, the pediatric eye is not just "a smaller adult eye", and pediatric vitreoretinal surgery has its unique challenges. Smaller gauge vitrectomy have evolved from 23-, 25- to 27-gauge, which gave surgeons more intraocular stability, but some issues ensue. The 25- and 27-gauge vitrectors are less stiff, which makes eye rotation and manipulation during vitrectomy more difficult. They are also easier to bend. These alterations force surgeons to change how they perform surgery with 20- or 23-gauge vitrectomy kit. For instance, surgeons have to rely on assistants to do scleral indentation to view the periphery of the eye without rotating it. However, a competent and experienced assistant is not always available, and surgeons rarely feel safe if the eye is not totally in their own hands. Secondly, the usual 27 mm vitrector is not designed for pediatric eyes. When using a 27 mm adult vitrector in children's eyes, a surgeon has to hold the vitrector differently from the usual manner in adult vitrectomy, and the kid's nose more easily obstructs the surgeon's hands. Thirdly, the far-too-long probe might easily damage the macula or even the choroid with a slight slip of the hand.

The short vitrectomy kit is a great improvement in pediatric retinal surgeries. Currently, the available option is Alcon's short vitrectomy pak with a probe length of 18mm. Recently, DORC system also announced their Ultra-Short vitrectomy kit. They claim the 27-gauge short vitrector is 25% shorter and 60% stiffer than the usual-length 27-gauge vitrector, which makes its length around 20.25 mm. With an even shorter length at 18 mm, the Alcon's short vitrectomy probe possibly brings more efficacy and safety in surgery. The pediatric eyes are notoriously "non-forgiving" with iatrogenic retinal breaks. Due to this reason, surgeons tend to be more conservative in operating pediatric eyes, and if the surgery or instruments are not in perfect condition, they are prone to do very little and leave the eyes for a second surgery later on. The introduction of a shorter, stiffer probe might change this and help surgeons achieve better surgical goals and as well as better outcomes for the patient. However, the use of 18 mm short vitrector is very limited throughout the world, and there are no reports on single-arm outcomes or a comparative study using 18 mm versus 27 mm vitrector. Therefore, this study is proposed to gain more knowledge regarding the possible advantages of short vitrectomy for pediatric retinal surgeries.

Patients under 18 years of age who are scheduled for vitrectomy surgery due to various etiologies will be prospectively enrolled. Intraoperative complication rates, including lens injury and iatrogenic retinal breaks, will be recorded. The bending rate of the vitrector probe will be documented. A questionnaire regarding the overall comfort and confidence level of operating with a short vitrectomy will be filled out by the primary surgeon. Postoperatively, the ocular anatomical and functional outcomes and the rate of a second surgery will be documented. These data will be analyzed and compared with our previous pediatric vitrectomy cohort (using the 27 mm vitrectomy) to demonstrate the difference between the 18 mm and 27 mm probes.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei-Chi Wu, MD, PhD; Phone Number: 886975365848; Email: weichi666@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Wei-Chi Wu, MD, PhD; Phone Number: 886975365848; Email: weichi666@gmail.com
    • Principal Investigator: Wei-Chi Wu, MD, PhD
    • Principal Investigator: Hung-Da Chou, MD
    • Sub-Investigator: Yih-Shiou Hwang, MD, PhD
    • Sub-Investigator: Kuan-Jen Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients less than 18 years old
• Need vitrectomy due to various etiologies, including retinopathy of prematurity, familial exudative vitreoretinopathy, persistent fetal vasculature, congenital cataract, lens dislocation, open-globe injury, vitreous hemorrhage, or other vitreoretinal diseases.

Exclusion Criteria:

• Patients who cannot cooperate fully with detailed ophthalmic examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short vitrector group; All enrolled patients will receive vitrectomy with the 18 mm short vitrectomy probe (25+ Short TOTALPLUS Vit Pak, 7500 CPM, Str Endoillum. w/ RFID, Alcon Laboratories Inc., Fort Worth, TX, USA.) for various vitreoretinopathies.	Device: Pars plana vitrectomy with a 18 mm short vitrector; Using the shorter 18 mm vitrector for various pediatric vitreoretinal surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery	Incidence of iatrogenic injury as assessed by the percentage of surgery with iatrogenic injury event	Intraoperatively
SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery	Incidence of intraoperative instrument bending as assessed by the percentage of surgery with instrument bending event	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery	Incidence of retinal detachment as assessed by ophthalmoscopy	6, 12, and 24 months postoperatively
EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery	Visual acuity as assessed by the Snellen Chart	6, 12, and 24 months postoperatively
SATISFACTION of surgeon while using 18 mm short vitrectomy probe for pediatric vitreoretinal surgery	The surgeon's satisfaction score as accessed by a satisfaction questionnaire that includes a scale from 0 (least satisfaction) to 5 (max satisfaction)	Intraoperatively

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Wei-Chi Wu, MD, PhD, Chang Gung Medical Foundation

Publications and helpful links

General Publications

• Gan NY, Lam WC. Special considerations for pediatric vitreoretinal surgery. Taiwan J Ophthalmol. 2018 Oct-Dec;8(4):237-242. doi: 10.4103/tjo.tjo_83_18.
• Yeh CT, Chen KJ, Liu L, Wang NK, Hwang YS, Chao AN, Chen TL, Lai CC, Wu WC. Visual and Anatomical Outcomes With Vitrectomy in Posterior or Combined Persistent Fetal Vasculature in an Asian Population. Ophthalmic Surg Lasers Imaging Retina. 2019 Jun 1;50(6):377-384. doi: 10.3928/23258160-20190605-06.
• Huang YC, Chu YC, Wang NK, Lai CC, Chen KJ, Hwang YS, Wu WC. IMPACT OF ETIOLOGY ON THE OUTCOME OF PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT. Retina. 2019 Jan;39(1):118-126. doi: 10.1097/IAE.0000000000001908.
• Wang NK, Tsai CH, Chen YP, Yeung L, Wu WC, Chen TL, Lin KK, Lai CC. Pediatric rhegmatogenous retinal detachment in East Asians. Ophthalmology. 2005 Nov;112(11):1890-5. doi: 10.1016/j.ophtha.2005.06.019.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Eye Diseases; Congenital Abnormalities; Eye Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Infant, Premature, Diseases; Telangiectasis; Vascular Diseases; Retinal Diseases; Retinopathy of Prematurity; Retinal Telangiectasis; Familial Exudative Vitreoretinopathies; Persistent Hyperplastic Primary Vitreous
• Other Study ID Numbers: 202101643A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes