UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039923 |
|---|---|
| Receipt number | R000045531 |
| Scientific Title | Effect of correction of off-axis aberration by eyeglass on visual function and subjective evaluation of patients after cataract surgery and patients with decreased central visual field sensitivity |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/03/27 09:47:42 |
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Basic information
Public title
Effect of correction of off-axis aberration by eyeglass on visual function and subjective evaluation of patients after cataract surgery and patients with decreased central visual field sensitivity
Acronym
Effect of correction of off-axis aberration by eyeglass on visual function and subjective evaluation of patients
Scientific Title
Effect of correction of off-axis aberration by eyeglass on visual function and subjective evaluation of patients after cataract surgery and patients with decreased central visual field sensitivity
Scientific Title:Acronym
Effect of correction of off-axis aberration by eyeglass on visual function and subjective evaluation of patients
Region
| Japan |
Condition
Condition
Eye after cataract surgery and Cases with decreased central visual field sensitivity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We developed eyeglasses to cancel off-axis aberration with standard model eyes. We investigate the effect of ocular off-axis aberration correction on visual function and subjective evaluation for eyes after cataract surgery and cases with decreased central visual field sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, contrast sensitivity, optical quality, subjective elaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional glasses for one month, one prescription
Interventions/Control_2
new glasses for one month, one prescription
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
Forty patients with direct consent (20 eyes after binocular cataract surgery, 20 eyes with reduced central visual field sensitivity). Age 20 and over, gender independent.
Key exclusion criteria
Exclusion criteria for post-cataract surgery group
Postoperative corrected decimal visual acuity of less than 1.0, those with lesions other than refractive error, those who have undergone ophthalmic surgery other than cataract surgery, those with corneal or retinal disease, amblyopia, those with systemic disease (diabetes, Multiple sclerosis, etc.), more than 5 months pregnant woman before examination, recent wear of hard contact lenses
Exclusion criteria for central visual field sensitivity reduction group
Patients who have undergone ophthalmic surgery in the past, who are pregnant for more than 5 months before the examination, or who have recently worn hard contact lenses
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
0427789662
kawa2008@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
0427789662
Homepage URL
kawa2008@kitasato-u.ac.jp
Sponsor or person
Institute
The Kitasato Institute
Institute
Department
Personal name
Funding Source
Organization
ITOH OPTICAL INDUSTRIAL CO.,LTD.
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
Kitasto University Hospital,
Address
IRB Office
Tel
042-778-8273
rinrib@med.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
| 2020 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045531
