UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035576 |
|---|---|
| Receipt number | R000040535 |
| Scientific Title | Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy. |
| Date of disclosure of the study information | 2019/01/17 |
| Last modified on | 2019/01/17 21:12:44 |
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Basic information
Public title
Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Acronym
Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Scientific Title
Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Scientific Title:Acronym
Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Region
| Japan |
Condition
Condition
granular corneal dystrophy, band keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the predictability of intraocular lens (IOL) power calculation using several corneal power measurements in eyes underwent phototherapeutic keratectomy (PTK).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOL power calculations were performed by the SRK/T formula using Total Corneal Refractive Power
Key secondary outcomes
Automated keratometry, Simulated keratometry, True Net Power
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
| 65 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
total of 42 eyes of 25 consecutive patients
Key exclusion criteria
Eyes with postoperative best spectacle-corrected visual acuity (BCVA) of >0.25 logMAR, and eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases, were excluded from the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Kamiya |
Organization
Kitasato University
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL
+81-42-778-9012
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Yoneyama |
Organization
Kitasato University
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL
+81-42-778-9012
Homepage URL
ryone.ry0@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 01 | Month | 17 | 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
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
| 2018 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approval number:B17-362
Management information
Registered date
| 2019 | Year | 01 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040535
