UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043395 |
|---|---|
| Receipt number | 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 02:47:51 |
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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
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
heba.ali@mu.edu.eg
Sponsor or person
Institute
Minia University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049462
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