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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-18
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who cannot cooperate fully with detailed ophthalmic examinations.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pars plana vitrectomy with a 18 mm short vitrector

    Device

    Using the shorter 18 mm vitrector for various pediatric vitreoretinal surgeries

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Short vitrector groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Intraoperatively
2

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

Time frame
Intraoperatively

Secondary outcomes

1

EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

Incidence of retinal detachment as assessed by ophthalmoscopy

Time frame
6, 12, and 24 months postoperatively
2

EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

Visual acuity as assessed by the Snellen Chart

Time frame
6, 12, and 24 months postoperatively
3

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)

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

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