UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029860 |
|---|---|
| Receipt number | R000034104 |
| Scientific Title | Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2018/11/08 11:16:57 |
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Basic information
Public title
Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses
Acronym
Efficacy of multifocal contact lens for eye after Efficacy of multifocal contact lens after implantation of monofocal intraocular lenses
Scientific Title
Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses
Scientific Title:Acronym
Efficacy of multifocal contact lens for eye after Efficacy of multifocal contact lens after implantation of monofocal intraocular lenses
Region
| Japan |
Condition
Condition
Pseudophakic eyes with monofocal intraocular lenses
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Alcon multifocal contact lens wear on monofocal intraocular lens implanted eyes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance, near and all distance visual acuities 1 and 3 months after multifocal contact lens wearing
Key secondary outcomes
Binocular Contrast sensitivity
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who has monofocal IOL implanted the capsule due to cataract surgery aged over 20 years and under 70.
(2) Patients who wear SCL habitual current or used to before cataract surgery
(3) Patients whose calculated power of bifocal SCL will be within the test CL power.
(4) Patients with distance corrective vision is 0.8 or over
(5) Patients who willing to be available for the follow-up observation after SCL prescription.
Note: It is advised to consider carefully for the adaption of the below patients
(1) Who has a refractive surgery history of LASIK, PRK, LRI and so on.
(2) Corneal endothelial cell density if less than 1,500/mm2
(3) Glaucoma
(4) History of uveitis or retinal detachment
(5) Diabetic retinopathy
(6) Excessive myopia
(7) Congenital eyelid abnormality
(8) Zinn's zonule rupture
(9) Case of mild secondary cataract
Key exclusion criteria
(1) Infectious diseases, inflammation, abnormalities in the anterior ocular segment, diseases contraindicated for CL wearing
(2) Manifest astigmatism over 1.75D
(3) Toric IOL, multifocal IOL implanted eye
(4) Serious postoperative complications
(5) Poorly controlled glaucoma, progressive diabetic retinopathy, active uveitis
(6) Implanted multifocal IOL in one eye
(7) In addition, patients who is judged inappropriate due to systemic or ophthalmologic diseases by an investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Miyata, MD, PhD |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
Address
6-3 Kurahara-cho, Miyakonojo
TEL
0986-22-1441
kmiyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Miyata, MD, PhD |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
Address
6-3 Kurahara-cho, Miyakonojo
TEL
0986-22-1441
Homepage URL
kmiyata@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Alcon
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 11 | Month | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: cohort study
Recruiting: patients who visit the hospital between October and December, 2017 and meet the inclusion criteria.
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034104
