Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520410
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-29
Brief Title:
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 surgeons comfort and reliability of using the shorter probe
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 childrens eyes a surgeon has to hold the vitrector differently from the usual manner in adult vitrectomy and the kids nose more easily obstructs the surgeons 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 Alcons 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 2025 mm With an even shorter length at 18 mm the Alcons 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
The short vitrectomy kit is a great improvement in pediatric retinal surgeries Currently the available option is Alcons 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 2025 mm With an even shorter length at 18 mm the Alcons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None