UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for therapeutic effect of corneal photovetrification against macular degeneration
Title of the study (Brief title)	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	Kazuo Tsubota
Organization	Minami Aoyama Eye Clinic
Division name	Ophthalmology
Address	3-3-11-4F, Kitaaoyama, Minato-ku, Tokyo
TEL	03-5772-1451
Email	tsubota@z3.keio.jp

Public contact
Name of contact person	Toshihide Kurihara
Organization	Minami Aoyama Eye Clinic
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022690