UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcomes of Toric Implantable Collamer Lens (T-ICL) and Toric Implantable Phakic Contact Lens (T IPCL) for correction of high myopia with astigmatism: Comparative study
Acronym	Comparison between Toric ICL and Toric IPCL for high myopia with astigmatism correction
Scientific Title	Clinical outcomes of Toric Implantable Collamer Lens (T-ICL) and Toric Implantable Phakic Contact Lens (T IPCL) for correction of high myopia with astigmatism: Comparative study
Scientific Title:Acronym	Comparison between Toric ICL and Toric IPCL for high myopia with astigmatism correction
Region	Africa

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

Objectives
Narrative objectives1	clinical and visual outcomes of two types of lenses (T-ICL and T IPCL)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	UCDVA, BCDVA, spherical error, cylindrical error, IOP, central corneal endothelium count
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Implantation of T-ICL in patients with myopia and high astigmatism and follow up period of 9 months postoperatively
Interventions/Control_2	Implantation of T IPCL in patients with myopia and high astigmatism and follow up period of 9 months postoperatively
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	21 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	Stable refraction, with myopia above 8 D and astigmatism above -10 D
Key exclusion criteria	Eyes with previous ocular trauma or surgery, other diseases including keratoconus, cataract, glaucoma, and uveitis. The presence of autoimmune diseases and Diabetes Mellitus were also excluded.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Heba Middle name Radi Last name AttaAllah
Organization	Faculty of Medicine/Minia University
Division name	Ophthalmology department
Zip code	61111
Address	Minia university, Egypt
TEL	+201002554107
Email	heba.ali@mu.edu.eg

Public contact
Name of contact person	1st name Heba Middle name Radi Last name AttaAllah
Organization	Minia University hospital
Division name	Ophthalmology
Zip code	61111
Address	Minia University/ Minia/Egypt
TEL	+201002554107
Homepage URL
Email	heba.ali@mu.edu.eg

Sponsor
Institute	Minia University
Institute
Department

Funding Source
Organization	Self funding
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	Minia university Hospita
Address	Minia university/ Minia
Tel	0020862342505
Email	heba.ali@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	Minia university hospital/Faculty of Medicine/Minia University

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results	The spherical error: In group A, the median preoperative spherical error was -10 which was improved significantly to -0.5 after 1 month and -0.3 after 6 and -0.25 after 9 months postoperatively. In group B, the median preoperative sphere was -11 which was improved significantly to -0.5 after 1 month and -0.3 after 6 and -0.25 after 9 months postoperatively. No statistically significant difference was found, when the two groups were compared pre-operatively or during the postoperative period
Results date posted	2021 Year 02 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures	Spherical error, cylindrical error, UCDVA, BCVDA, IOP, ECC
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 15 Day
Date of IRB	2019 Year 11 Month 28 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2021 Year 01 Month 19 Day
Date of closure to data entry	2021 Year 01 Month 20 Day
Date trial data considered complete	2021 Year 01 Month 22 Day
Date analysis concluded	2021 Year 01 Month 27 Day

Other
Other related information

Management information
Registered date	2021 Year 02 Month 20 Day
Last modified on	2021 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049462

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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