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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044421
Receipt No. R000050741
Scientific Title CLINICAL OUTCOMES OF BEVELED TIP, ULTRA-HIGH SPEED, 25-GAUGE PARS PLANA VITRECTOMY SYSTEM
Date of disclosure of the study information 2021/06/03
Last modified on 2021/06/03

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Basic information
Public title CLINICAL OUTCOMES OF BEVELED TIP, ULTRA-HIGH SPEED, 25-GAUGE PARS PLANA VITRECTOMY SYSTEM
Acronym UPVIS
Scientific Title CLINICAL OUTCOMES OF BEVELED TIP, ULTRA-HIGH SPEED, 25-GAUGE PARS PLANA VITRECTOMY SYSTEM
Scientific Title:Acronym UPVIS
Region
Asia(except Japan)

Condition
Condition Vitreo-retinal diseases treatable by surgery
Classification by specialty
Surgery in general Ophthalmology Not applicable
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of a 25-gauge, 10,000 cut per minute (CPM), bevel tip, cutter probe among eyes undergoing pars plana vitrectomy (PPV)

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Ability of a 25-gauge, 10,000 CPM, bevel tip cutter probe to complete the surgical objectives for eyes undergoing PPV
Key secondary outcomes Presence of wound leak at end of surgery
Pain assessment scores
Postoperative intraocular pressures
Core vitrectomy duration (from start of vitrectomy to shift to peripheral shaving setting)
Frequency of need for adjunctive surgical instrumentation among eyes with proliferative retinopathy or proliferative diabetic retinopathy
Adverse events (eg. retinal tear, retinal detachment)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 25-gauge, bevel tip, 10000 cut per minute vitrectomy probe
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing primary pars plana vitrectomy for retinal and vitreous disorders
Clear cornea at least 8 mm
Pupil diameter after dilation of at least 5 mm
Key exclusion criteria Significant Corneal opacification
Scleral disorders
Deficient capsular stability and integrity
Inability to complete a 3 month follow up visits
External eye infection
Severe dry eye
Glaucoma or ocular hypertension
Prior glaucoma surgery
Prior vitrectomy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Harvey
Middle name S
Last name Uy
Organization Peregrine Eye And Laser Institute
Division name Research Division
Zip code 1209
Address Morning Star Center, 5/F, 347 Senator Gil Puyat Avenue, Bel Air, Makati, Philippines
TEL 63288900115
Email harveyuy@yahoo.com

Public contact
Name of contact person
1st name Harvey
Middle name S
Last name Uy
Organization Peregrine Eye and Laser Institute
Division name Research Division
Zip code 1209
Address Morning Star Center, 5/F, 347 Senator Gil Puyat Avenue, Bel Air, Makati, Philippines
TEL 63288900115
Homepage URL http://peregrineeye.com
Email harveyuy@yahoo.com

Sponsor
Institute Peregrine Eye and Laser Institute
Institute
Department

Funding Source
Organization Peregrine Eye and Laser Institute
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Philippines

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Peregrine Eye and Laser Institute - Institutional Review Board
Address Peregrine Eye And Laser Institute, Morning Star Center, 5/F
Tel 63288900115
Email hr@peregrineeye.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 03 Day

Related information
URL releasing protocol Per request from PI
Publication of results Unpublished

Result
URL related to results and publications Not applicable
Number of participants that the trial has enrolled 50
Results The surgical objectives were achieved in all 50 eyes. The mean total operative time, core, shave and total vitrectomy times were 1891, 204, 330, 534 seconds, respectively. The mean number of surgical steps was 4.3. The mean number of times an ancillary instrument was placed inside the eye was 4.5. The mean CDVA at the three-month postoperative visit improved by 0.53 logMAR units (P=0.001).
Results date posted
2021 Year 06 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Fifty consecutive eyes underwent PPV for various indications. The mean patient age was 57.2 (range, 16 to 84). Baseline CDVA ranged from 20/20 to light perception vision with a mean CDVA of 1.24 logMAR units (Snellen Equivalent = 20/347). The mean preoperative IOP was 13.2 (range, 4 to 30) mmHg. The surgical indications were MH (22%), RRD (20%), vitreous hemorrhage (20%), ERM (12%), TRD (10%), DIS (6%), vitritis (6%) and RLF (4%).
Participant flow All eyes underwent comprehensive eye exam, pars plana vitrectomy, and 3 month follow up.
Adverse events Postoperative adverse events included elevated IOP (8%), hypotony (6%), and re-detachment (2%). None of the eyes required sclerotomy suturing. Majority (82%) of patients reported no postoperative discomfort.
Outcome measures Completion of surgical objectives
Plan to share IPD Print and presentation
IPD sharing Plan description Submit to indexed medical journal for publication

Submit to regional retina society meeting

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 12 Month 10 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 04 Month 24 Day
Last follow-up date
2020 Year 01 Month 24 Day
Date of closure to data entry
2020 Year 01 Month 24 Day
Date trial data considered complete
2020 Year 01 Month 24 Day
Date analysis concluded
2020 Year 02 Month 24 Day

Other
Other related information

Management information
Registered date
2021 Year 06 Month 03 Day
Last modified on
2021 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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