UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019629 |
|---|---|
| Receipt number | R000022690 |
| Scientific Title | Evaluation for therapeutic effect of corneal photovetrification against macular degeneration |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2018/05/08 09:10:19 |
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Basic information
Public title
Evaluation for therapeutic effect of corneal photovetrification against macular degeneration
Acronym
Evaluation for CPV against macular degeneration
Scientific Title
Evaluation for therapeutic effect of corneal photovetrification against macular degeneration
Scientific Title:Acronym
Evaluation for CPV against macular degeneration
Region
| Japan |
Condition
Condition
Dry type age-related macular degeneration, wet type age-related macular degeneration, and myopic macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Corneal photovetrification (CPV) is a therapeutic opportunity for macular degeneration by changing the structure of cornea and modifying the distribution of light illumination. In this study, we will evaluate the safety and the efficiency of this procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Best corrected distance and near visual acuity
2. Functional visual acuity
3. Contrast sensitivity
4. Subjective symptoms evaluated by VFQ-25 and happiness questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Corneal photovitrification: CPV
On the operating day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as age-related macular degeneration (wet or dry) or myopic macular degeneration
2. Patients whose visual acuity ranged between 0.02 to 0.3
3. Patients whose visual acuity can be improved 2 lines (10 letters) by 2.5x telescope using ETDRS charts
4. Patients who have normal corneal structure evaluated by corneal topography
5. Patients who do not wear contact lenses or who can take of contact lenses 1 week (for SCL) or 3 weeks prior to the procedure
6. Patients who can follow the examination schedule
7. Patients who can sign the informed consent form
Key exclusion criteria
1. Patients who have ocular diseases beside macular degeneration
2. Patients who have corneal astigmatism larger than 3 diopters
3. Patient who have corneal surgical history
4. Patient who are considered as not appropriate by the doctors
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Minami Aoyama Eye Clinic
Division name
Ophthalmology
Zip code
Address
3-3-11-4F, Kitaaoyama, Minato-ku, Tokyo
TEL
03-5772-1451
tsubota@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihide Kurihara |
Organization
Minami Aoyama Eye Clinic
Division name
Ophthalmology
Zip code
Address
3-3-11-4F, Kitaaoyama, Minato-ku, Tokyo
TEL
03-5772-1451
Homepage URL
kurihara@z8.keio.jp
Sponsor or person
Institute
Minami Aoyama Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Optimal Acuity Corporation
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2015 | Year | 11 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022690
