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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002135
Receipt No. R000002607
Scientific Title A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Date of disclosure of the study information 2009/06/29
Last modified on 2009/06/29

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Basic information
Public title A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Acronym A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Scientific Title A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Scientific Title:Acronym A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients
Region
Japan

Condition
Condition Emmetropic presbyopes
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the application of the AcuFocus(TM) Corneal Inlay (ACI) implanted intra-stromally in emmetropic presbyopes for the improvement of near vision.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Uncollected distance visual acuity and uncollected near visual acuity
Key secondary outcomes Patient satisfaction
Safety

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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Emmetropic presbyopes who have provided informed consent for ACI implantation, and meet all the following criteria:
1. Emmetropes needing a magnitude of +0.75D to +2.50D of reading glasses
2. Distance visual acuity correctable to at least 0.8 in both eyes
3. Preoperative spherical equivalent of plano defined as +0.50D to -1.25D with no more than 0.75D of refractive cylinder in the eye to be implanted
4. Must discontinue their soft contact lenses for at least one week prior to ACI pre-operative examination
5. Minimum central corneal thickness of >= 500 microns in the eye to be implanted.
6. Corneal power of >= 39.00D and <= 49.00D in all meridians in the eye to be implanted
7. Endothelial cell count >= 2000 cells/mm2 in the eye to be implanted
8. Able to return for scheduled follow-up examinations for 12 months after surgery
9. Written informed consent given.
Key exclusion criteria 1. Active or recurrent ocular pathology, including eyelid disease, corneal abnormalities (e.g. keratoconus, endothelial dystrophy), cataracts, glaucoma, ocular hypertension, macular degeneration, retinal detachment or any other ocular pathology that would prevent an acceptable visual outcome in the eye to be implanted
2. With a history of steroid-responsive rise in intraocular pressure.
3. Dry eye as determined by objective testing.
4. Using systemic medications with significant ocular side effects, including medications known to exacerbate or induce moderate to severe dry eye.
5. Abnormal threshold visual field.
6. With a history of herpes zoster or herpes simplex keratitis.
7. With a history of diagnosed diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
8. Chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised patients.
9. Using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
10. Sensitivity to planned study concomitant medications.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanjiro Masuda
Organization Masuda memorial eye care clinic
Division name Director
Zip code
Address 5F Tsutsumi Bldg. 1-13-12, Shinbashi Minato-ku Tokyo, Japan, 105-0004
TEL 03-3593-0381
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Morifuji
Organization Mebix, Inc.
Division name The 3rd Research Promotion Group
Zip code
Address 1-3-25, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL 03-5842-3901
Homepage URL
Email

Sponsor
Institute Japanese Research Center of Refractive
Surgery
Institute
Department

Funding Source
Organization Japanese Research Center of Refractive Surgery
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
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
2009 Year 06 Month 29 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
Date of protocol fixation
2009 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objective: To evaluate the application of the AcuFocus(TM) Corneal Inlay (ACI) implanted intra-stromally in emmetropic presbyopes for the improvement of near vision.

Management information
Registered date
2009 Year 06 Month 29 Day
Last modified on
2009 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002607

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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