UMIN-CTR Clinical Trial

Basic information
Public title	Progression of posterior vitreous detachment (PVD) after cataract surgery in non-highly myopic patients
Acronym	Posterior vitreous detachment after cataract surgery
Scientific Title	Comparison of progression of posterior vitreous detachment (PVD) between eyes that underwent cataract surgery and eyes that did not undergo surgery in non-highly myopic patients: a case-control study
Scientific Title:Acronym	Comparison of progression of PVD between eyes that underwent cataract surgery and eyes that did not undergo surgery
Region	Japan

Condition
Condition	cataract, posterior vitreous detachment
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compared the progression of posterior vitreous detachment (PVD) for up to 12 months postoperatively between eyes that underwent cataract surgery and eyes that did not undergo surgery in non-highly myopic patients.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to compare the progression of stage of posterior vitreous detachment (PVD) between eyes that underwent cataract surgery and eyes that did not undergo surgery in non-highly myopic patients.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) We compared the mean PVD stage at baseline (2 days postoperatively in the surgery group), and 1, 3, 6, and 12 months postbaseline. 2) We compared the incidence of progression to complete PVD for up to 12 months after baseline.
Key secondary outcomes	3) We compared the incidence of PVD-related retinal disease.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients scheduled for cataract surgery is consecutively screened. Patients whose posterior vitreous detachment (PVD) can be classified by a classification system described Itakura and Kishi using swept-source optical coherence tomography (OCT) before or 2 days after surgery.
Key exclusion criteria	Preoperative exclusion criteria are complete PVD (stage 4), macular disease (macular epithelium, VRTS, etc.), diabetic retinopathy, and high myopia (axial length 26 mm or more). Postoperative exclusion criteria are intraoperative complications, and patients who cannot be classified according to the classification system.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name KEN Middle name Last name HAYASHI
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
Zip code	812-0011
Address	4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL	092-431-1680
Email	hayashi-ken@hayashi.or.jp

Public contact
Name of contact person	1st name KEN Middle name Last name HAYASHI
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
Zip code	812-0011
Address	4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL	092-431-1680
Homepage URL
Email	hayashi-ken@hayashi.or.jp

Sponsor
Institute	Hayashi Eye Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Hayashi Eye Hospital
Address	4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
Tel	092-431-1680
Email	mihara-seiya@hayashi.or.jp

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	林眼科病院（福岡県）/Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 15 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	250
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Two-hundred and fifty eyes of 250 patients were enrolled.
Participant flow	After 250 patients were enrolled, 13 patients were lost to follow-up. The data of 237 eyes remained in the analysis.
Adverse events	None
Outcome measures	1) The mean PVD stage at baseline, 1, 3, 6, and 12 months postoperatively and 2) incidence of progression to complete PVD within 12 months after baseline.
Plan to share IPD	No
IPD sharing Plan description	No

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 28 Day
Date of IRB	2018 Year 08 Month 28 Day
Anticipated trial start date	2018 Year 08 Month 28 Day
Last follow-up date	2020 Year 09 Month 11 Day
Date of closure to data entry	2021 Year 01 Month 15 Day
Date trial data considered complete	2021 Year 01 Month 15 Day
Date analysis concluded	2021 Year 01 Month 30 Day

Other
Other related information	Although we evaluated the incidence of PVD-related retinal complications, sex-related differences in PVD progression, and association with axial length, the sample size was not large enough for subgroup analyses, such as of the incidence of PVD-related retinal complications and sex-related differences in PVD progression.

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049079