UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044421 |
|---|---|
| Receipt number | 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 21:48:44 |
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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
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
harveyuy@yahoo.com
Sponsor or person
Institute
Peregrine Eye and Laser Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050741
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