UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055207 |
|---|---|
| Receipt number | R000061820 |
| Scientific Title | Evaluation of postoperative visual function and patient satisfaction with the TECNIS Eyhance Optiblue using the monovision method. |
| Date of disclosure of the study information | 2024/08/25 |
| Last modified on | 2024/08/09 16:43:30 |
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Basic information
Public title
Evaluation of postoperative visual function and patient satisfaction with the TECNIS Eyhance Optiblue using the monovision method.
Acronym
Evaluation of postoperative visual function and patient satisfaction with the TECNIS Eyhance Optiblue using the monovision method.
Scientific Title
Evaluation of postoperative visual function and patient satisfaction with the TECNIS Eyhance Optiblue using the monovision method.
Scientific Title:Acronym
Evaluation of postoperative visual function and patient satisfaction with the TECNIS Eyhance Optiblue using the monovision method.
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine postoperative visual function and patient satisfaction in mini-monovision cases using the TECNIS Eyhance Optiblue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One month after the second eye surgery, uncorrected distance visual acuity (CDVA and UDVA, respectively), uncorrected intermediate visual acuity at 70 cm (UIVA), and uncorrected near visual acuity at 40 cm (UNVA)
Key secondary outcomes
patient satisfaction
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
| 84 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients who used Tecnis Eye Hans OptiBlue or Tecnis Eye Hans OptiBlue Toric II in both eyes
2.Men and women between the ages of 40 and 84
3.Patients with preoperative corneal astigmatism of 2.5 D or less
4.Patients with distance-corrected visual acuity of 1.0 or better at 1 month postoperatively
5.Patients who underwent cataract surgery with binocular correct vision target or mini-monovision method
Key exclusion criteria
1.Patients with a history of LASIK
2.Patients with a history of previous internal ophthalmic surgery
3.Patients with ocular diseases that affect visual function
4.Patients with other systemic or ocular diseases for which the investigator or principal investigator determines that inclusion is inappropriate
Target sample size
999
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Fujita |
Organization
FUJITA EYE CLINIC
Division name
Ophthalmology
Zip code
770-0026
Address
6-6-27, SAKO, Tokushima-shi, Tokushima, Japan
TEL
0800-222-1010
fujitaec@gmail.com
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Nomura |
Organization
FUJITA EYE CLINIC
Division name
Ophthalmology
Zip code
770-0026
Address
6-6-27, SAKO, Tokushima-shi, Tokushima, Japan
TEL
0800-222-1010
Homepage URL
nomura@fujitaec.or.jp
Sponsor or person
Institute
FUJITA EYE CLINIC
Institute
Department
Personal name
Funding Source
Organization
AMO Japan K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061820
