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Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter

Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04404296
Acronym
HYPE
Enrollment
50
Registered
2020-05-27
Start date
2021-04-01
Completion date
2022-01-30
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dislocated Intraocular Lens Into Vitreous, Epiretinal Membrane, Macular Holes, Retained Lens Fragments, Retinal Detachment, Vitrectomy, Vitreous Hemorrhage

Keywords

Small gauge vitrectomy probe, 20000 cut per minute, Microincisional vitrectomy system

Brief summary

Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases

Detailed description

We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.

Interventions

DEVICE25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy

Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe

Sponsors

Alcon Research
CollaboratorINDUSTRY
Peregrine Eye and Laser Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Interventional case series

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.

Exclusion criteria

* History of prior PPV, glaucoma, scleral thinning, and active or recent history of (\<3 months) ocular or extra-ocular infection

Design outcomes

Primary

MeasureTime frameDescription
Operative time: Total6 monthsFrom insertion of first trocar to removal of last trocar, measured in seconds using stopwatch

Secondary

MeasureTime frameDescription
Pain scoring6 monthsVisual Analogue scale (0 to 4)
Adverse eventsUp to 3 months after surgeryIntra- and Postoperative complications
Number of times ancillary instruments placed in eye6 monthsCount

Countries

Philippines

Contacts

Primary ContactHarvey S Uy, MD
harveyuy@yahoo.com639175239332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026