UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040137 |
|---|---|
| Receipt number | R000045768 |
| Scientific Title | Clinical Outcomes of Simultaneous Phototherapeutic Keratectomy and Photoastigmatic Keratectomy. |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2025/04/17 11:13:16 |
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Basic information
Public title
Clinical Outcomes of Simultaneous Phototherapeutic Keratectomy and Photoastigmatic Keratectomy.
Acronym
Outcomes of Simultaneous Phototherapeutic Keratectomy and Photoastigmatic Keratectomy.
Scientific Title
Clinical Outcomes of Simultaneous Phototherapeutic Keratectomy and Photoastigmatic Keratectomy.
Scientific Title:Acronym
Outcomes of Simultaneous Phototherapeutic Keratectomy and Photoastigmatic Keratectomy.
Region
| Japan |
Condition
Condition
Granular corneal dystrophy and band keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the outcomes of simultaneous phototherapeutic keratectomy (PTK) and photoastigmatic keratectomy (PAK)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, astigmatism
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Granular corneal dystrophy and band keratopathy with refractive astigmatism of 1 diopter (D) or more
Key exclusion criteria
Other corneal diseases, including keratoconus.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | Kamiya |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1, Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1, Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1, Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
kamiyak-tky@umin.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 | 13 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
30
Results
Simultaneous therapeutic keratectomy and astigmatism correction surgery significantly improved corrected visual acuity and was effective in correcting astigmatism. The results suggest its usefulness as a treatment method for granular corneal degeneration and zonular degeneration with astigmatism.
Results date posted
| 2025 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
GCD/BSK
Participant flow
Retrospective chart review.
Adverse events
None
Outcome measures
Visual acuity, refraction, corneal disorders, refractive disorders, complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
corrected distance visual acuity, uncorrected distance visual acuity, manifest spherical equivalent, refractive astigmatism (manifest cylinder), corneal astigmatism, corneal higher-order aberrations, and complications.
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045768
