UMIN-CTR Clinical Trial

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
Email	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
Email	asmaa.anwar@mu.edu.eg

Sponsor
Institute	Non
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051823