UMIN-CTR Clinical Trial

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