HYPE: Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter
Sponsor
Peregrine Eye and Laser Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04404296
Collaborator
Alcon Research (Industry)
50
1
1
10
5
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interventional case seriesInterventional case series
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy
Actual Study Start Date
:
Apr 1, 2021
Anticipated Primary Completion Date
:
Oct 30, 2021
Anticipated Study Completion Date
:
Jan 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 25-gauge 20000 PPV Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe |
Device: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
|
Outcome Measures
Primary Outcome Measures
- Operative time: Total [6 months]
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
Secondary Outcome Measures
- Pain scoring [6 months]
Visual Analogue scale (0 to 4)
- Adverse events [Up to 3 months after surgery]
Intra- and Postoperative complications
- Number of times ancillary instruments placed in eye [6 months]
Count
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peregrine Eye and Laser Instittute | Makati City | MM | Philippines | 1209 |
Sponsors and Collaborators
- Peregrine Eye and Laser Institute
- Alcon Research
Investigators
- Principal Investigator: Harvey S Uy, MD, Peregrine Eye and Laser Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Harvey Siy Uy,
Medical Director,
Peregrine Eye and Laser Institute
ClinicalTrials.gov Identifier:
NCT04404296
Other Study ID Numbers:
- 20190101
First Posted:
May 27, 2020
Last Update Posted:
Jun 4, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Harvey Siy Uy,
Medical Director,
Peregrine Eye and Laser Institute
Additional relevant MeSH terms: