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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019629
Receipt No. 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

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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
Email 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
Email kurihara@z8.keio.jp

Sponsor
Institute Minami Aoyama Eye Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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