UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045383 |
|---|---|
| Receipt number | R000051823 |
| Scientific Title | Anatomical Effects of Implantable Phakic Contact Lens on correction of myopia |
| Date of disclosure of the study information | 2021/09/05 |
| Last modified on | 2021/09/05 08:18:41 |
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Basic information
Public title
Anatomical and visual Effects of Implantable Phakic Contact Lens on correction of myopia
Acronym
Anatomical and visual effect of Implantable Phakic IOL
Scientific Title
Anatomical Effects of Implantable Phakic Contact Lens on correction of myopia
Scientific Title:Acronym
Anatomical and visual Effects of Implantable Phakic Contact Lens on correction of myopia
Region
| Africa |
Condition
Condition
Efficacy and safety of implantable phakic IOL on correction of high myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anatomical and visual effect
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Although Implantable Phakic IOL cause changes on anterior segment parameters it is safe for usage
Key secondary outcomes
Implantable phakic IOL is safe and effective in treatment of high myopia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
surgery (implantation of IOL)
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
| 19 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with high myopic error with thin cornea , not suitable for corneal refractive surgery
Key exclusion criteria
Exclusion criteria included patients with endothelial cell density (ECD) < 2,000 cells/mm2, anterior chamber depth (ACD) < 3 mm, astigmatism < 1.00 D, and patients with keratoconus or other corneal disorders. Also, patients with glaucoma, uveitis, any degree of cataract, myopic CNV, macular hole, previous retinal detachment surgery, intravitreal injections, and any other ocular disorder that may affect visual outcomes, were excluded from the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Asmaa |
| Middle name | Anwar |
| Last name | Mohamed |
Organization
Faculty of medicine ,Minia university
Division name
ophthalmology departement
Zip code
61623
Address
24th 6 october street taha hussein minya
TEL
01006048882
asmaa.anwar@mu.edu.eg
Public contact
Name of contact person
| 1st name | Asmaa |
| Middle name | Anwar |
| Last name | Mohamed |
Organization
Minis University Hospital
Division name
Heba Radi Attallah
Zip code
61623
Address
24th 6 october street taha hussein minya
TEL
01002554107
Homepage URL
asmaa.anwar@mu.edu.eg
Sponsor or person
Institute
Non
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Egypt
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asmaa Anwar Mohamed
Address
24th 6 october street taha hussein minya
Tel
0100604882
asmaa.anwar@mu.edu.eg
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
Mina University Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
The mean log-MAR base line uncorrected visual acuity significantly improved
Publication of results
Unpublished
Result
URL related to results and publications
The mean log-MAR base line Uncorrected visual acuity significantly improved
Number of participants that the trial has enrolled
60
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051823
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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