UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045132 |
|---|---|
| Receipt number | R000051561 |
| Scientific Title | Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/08/21 19:01:03 |
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Basic information
Public title
Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation.
Acronym
Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens.
Scientific Title
Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation.
Scientific Title:Acronym
Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens.
Region
| Japan |
Condition
Condition
Presybyopia after Cataract Surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess visual performance and patient satisfaction of multifocal contact lenses in eyes having monofocal intraocular lens (IOL) implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity at all distances, Contrast sensitivity function.
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eyes with corneal astigmatism of 1.5 diopter (D) or less
Eyes with postoperative best corrected visual acuity of 0.1 logMAR or better
Key exclusion criteria
Eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases
Eyes developing any intraoperative or postoperative complications
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kamiya |
| Middle name | |
| Last name | Kazutaka |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kamiya |
| Middle name | |
| Last name | Kazutaka |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyata Eye Hospital
Address
6-3, Kurahara, Miyakonojo, Miyazaki
Tel
0986-22-1441
kamiyak-tky@umin.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34705259/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34705259/
Number of participants that the trial has enrolled
142
Results
both multifocal IOLs and CLs provided good near-to-distance binocular vision and subsequent high patient satisfaction in daily activities with acceptable contrast sensitivity.
Results date posted
| 2022 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
multifocal intraocular lens (IOL)-implanted eyes and multifocal contact lens (CL)-wearing eyes undergoing monofocal IOL implantation.
Participant flow
retrospectiver review of the clinical charts.
Adverse events
No significant complications
Outcome measures
visual acuity at all distances (0.3, 0.5, 0.7, 1, and 5 m), contrast sensitivity function, patient satisfaction score, and the rate of spectacle independence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine visual acuity at all distances (0.3, 0.5, 0.7, 1, and 5 m), contrast sensitivity (CS) function, patient satisfaction, and the independence of spectacle correction, in both the multifocal IOL and multifocal CL groups.
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051561
