UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051272 |
|---|---|
| Receipt number | R000058477 |
| Scientific Title | Effects of Ocular Off-Axis Aberration Correction with Glasses on Visual Function and Subjective Evaluation of Intraocular Lens Implanted Eyes after Cataract Surgery |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2024/12/06 22:17:32 |
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Basic information
Public title
Effects of Ocular Off-Axis Aberration Correction with Glasses on Visual Function and Subjective Evaluation of Intraocular Lens Implanted Eyes after Cataract Surgery
Acronym
Effect of off-axis aberration correction on eyes after cataract surgery
Scientific Title
Effects of Ocular Off-Axis Aberration Correction with Glasses on Visual Function and Subjective Evaluation of Intraocular Lens Implanted Eyes after Cataract Surgery
Scientific Title:Acronym
Effect of off-axis aberration correction on eyes after cataract surgery
Region
| Japan |
Condition
Condition
Intraocular lens implanted eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ocular off-axis aberration correction by spectacles on visual function and subjective evaluation of intraocular lens implanted eyes for eyes after cataract surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast Sensitivity
Key secondary outcomes
Visual acuity and subjective questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eyeglasses (off-axis aberration correcting lens design)
Interventions/Control_2
Eyeglasses (Rotationally Asymmetric Aspheric Lens design)
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
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study subjects will be those who have undergone cataract surgery for more than 6 months. The number of study subjects will be those who have no problems with cornea or retina.
Key exclusion criteria
Postoperative visual acuity less than 1.0, recent hard contact lens wearers, those with corneal or retinal disease, those with low vision, those with systemic disease, those over 5 months pregnant, and hard contact lens wearers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKUSHI |
| Middle name | |
| Last name | KAWAMORITA |
Organization
Kitasato University School of Allied Health Sciences
Division name
Department of Orthoptics and Visual Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa
TEL
042-778-9662
kawa2008@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKUSHI |
| Middle name | |
| Last name | KAWAMORITA |
Organization
Kitasato University School of Allied Health Sciences
Division name
Department of Orthoptics and Visual Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa
TEL
042-778-9662
Homepage URL
kawa2008@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
ITOH OPTICAL INDUSTRIAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kitasato University School of Allied Health Sciences
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa
Tel
042-778-9662
kawa2008@kitasato-u.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
| 2023 | Year | 06 | Month | 07 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058477
