UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039844 |
|---|---|
| Receipt number | R000045427 |
| Scientific Title | Comparison of changes in refractive prediction error after cataract surgery among eyes that received three types of single-piece acrylic intraocular lenses: a single-blinded randomized parallel comparative study |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2020/03/17 12:08:26 |
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Basic information
Public title
Changes in Refractive Prediction Error After Cataract Surgery in Eyes That Received Three Types of Single-Piece Acrylic Intraocular Lenses
Acronym
Refractive prediction error with single-piece intraocular lens
Scientific Title
Comparison of changes in refractive prediction error after cataract surgery among eyes that received three types of single-piece acrylic intraocular lenses: a single-blinded randomized parallel comparative study
Scientific Title:Acronym
Single-blinded randomized comparison of changes in prediction error among eyes that received three types of single-piece acrylic intraocular lenses
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare early changes in refractive prediction error after cataract surgery among eyes that received 3 types of single-piece acrylic intraocular lenses
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to compare changes in refractive prediction error (PE) after cataract surgery among eyes that received 3 types of single-piece acrylic intraocular lenses. We examined clinically relevant difference of 3 types of single-piece acrylic IOLs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Refractive prediction error (PE), and changes in PE was examined at 1 days, and 1 and 2 months postoperatively, and were compared among 3 IOL groups.
Key secondary outcomes
To clarify the causes why did the changes in PE during 2 months after surgery differ among these IOLs, we examined the factors that significantly affect the changes in PE
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
One-hundreds and ninety-five eyes of 195 patients who were scheduled to underwent cataract surgery and implantation of single-piece acrylic IOL was enrolled in this study.
Key exclusion criteria
Exclusion criteria were eyes with corneal disorders; eyes with vitreous opacity or retinal disease; eyes with ocular surface dryness; eyes scheduled for extracapsular or intracapsular cataract extraction; history of ocular surgery or inflammation; eyes with pseudoexfoliation; eyes with a pupil diameter < 4.0 mm after mydriasis; eyes with marked irregular corneal astigmatism; eyes with patient refusal; and any anticipated difficulties with examination or 2-months follow-up.
Target sample size
195
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-city, 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-city, 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
Hayashi Eye Hospital
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-city, 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
| 2020 | Year | 03 | Month | 18 | 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
195
Results
The mean PE did not differ significantly among groups at 1 days and 1 month postoperatively, and were significantly less in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P<.0006). The mean change in PE between 1 day and 2 months after surgery was significantly less in the SN60WF group than in the other groups (P=.0062).
Results date posted
| 2020 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
One-hundred and ninety-five eyes of 195 patients were enrolled.
Participant flow
After 195 patients were enrolled, 3 patients were lost to follow-up. data of 192 eyes remained in the analysis.
Adverse events
None
Outcome measures
Manifest spherical equivalent value (MRSE), PE, and changes in PE at 1day, and 1 and 2 months after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 26 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 03 | Day |
Other
Other related information
It is well known that refractive states change toward myopia immediately or early after cataract surgery. In this study, the results showed that the postoperative refraction and prediction error (PE) differ significantly among the 3 types of single-piece acrylic IOLs; they were less with the SN60WF compared with the XY-1 and ZCB00V. Changes in PE during 2 months was also less with the SN60WF than with the other IOLs, suggesting that postoperative refractive stability differ even among single-piece acrylic IOLs.
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045427
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