UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042994 |
|---|---|
| Receipt number | R000049079 |
| 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 |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/13 12:26:06 |
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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
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
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049079
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