UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046814 |
|---|---|
| Receipt number | R000052927 |
| Scientific Title | Intermediate visual function of monofocal intraocular lenses |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2024/03/07 09:37:03 |
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Basic information
Public title
Intermediate visual function of monofocal intraocular lenses
Acronym
Intermediate visual function of monofocal intraocular lenses
Scientific Title
Intermediate visual function of monofocal intraocular lenses
Scientific Title:Acronym
Intermediate visual function of monofocal intraocular lenses
Region
| Japan |
Condition
Condition
pseudophakia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the function visual acuity and patient satisfaction of the Tecnis Eyhance, compared to a conventional monofocal IOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binocular function visual acuity(Far, 66cm, 40cm)
Key secondary outcomes
Questionnaire (Near Activity Visual Questionnaire(NAVQ), Visual Analogue Scale(VAS))
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with monofocal intraocular lenses (Technis One piece or Technis Eyhance) inserted into both eyes and followed up for 3 weeks or more after surgery
2.Postoperative refractive power does not matter
3.Men and women over 20 years old
4.Patients with oral consent to participate in this study
5.Postoperative corrected visual acuity => 0.8
6.No systemic diseases or eye diseases affecting visual function
Key exclusion criteria
1.Patients who left and right surgery dates are different by one month or more
2.Patients with intraoperative and postoperative complications
3. Post refractive surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
kazunonegishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMO Japan K.K
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations
1) Binocular function visual acuity (Far, 66cm, 40cm)
2) Questionnaire:
Near Activity Visual Questionnaire(NAVQ),Visual Analogue Scale(VAS)
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052927
