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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043395
Receipt No. R000049462
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
Date of disclosure of the study information 2021/02/20
Last modified on 2021/02/20

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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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