UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061027 |
|---|---|
| Receipt number | R000069835 |
| Scientific Title | Outcomes and feasibility of Visian Toric vs. Eyecryl Toric Implantable Collamer Lenses in Resource-Limited Settings. |
| Date of disclosure of the study information | 2026/03/26 |
| Last modified on | 2026/03/23 22:47:21 |
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Basic information
Public title
Comparison of two lenses for myopia correction
Acronym
Myopia correction with implantable lens
Scientific Title
Outcomes and feasibility of Visian Toric vs. Eyecryl Toric Implantable Collamer Lenses in Resource-Limited Settings.
Scientific Title:Acronym
Implantable Collamer Lens
Region
| Asia(except Japan) |
Condition
Condition
Myopic Astigmatism
Classification by specialty
| Medicine in general | Surgery in general | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore safety, efficacy and feasibility of Visian Toric and Eyecryl Toric ICL for myopic astigmatism correction in resource limited settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Refractive Predictability, safety and efficacy
Key secondary outcomes
Change in intraocular pressure, anterior chamber depth (ACD) and endothelial cell density were secondary outcome measures.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Visian Toric ICL implantation
Interventions/Control_2
Eyecryl Toric ICL implantation
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
myopia
Astigmatism
endothelial cell count
ACD
IOP
Key exclusion criteria
ocular trauma
Prior surgery
keratoconus,
cataract,
glaucoma,
uveitis
autoimmune diseases
diabetes
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Rahul |
| Middle name | |
| Last name | Bhargava |
Organization
GS Medical College
Division name
Uttar pradesh
Zip code
245304
Address
Pilkhuwa
TEL
9999055223
brahul_2371@yahoo.co.in
Public contact
Name of contact person
| 1st name | Pooja |
| Middle name | |
| Last name | Bargujar |
Organization
Yashodha Medicity
Division name
Ghaziabad
Zip code
201303
Address
Indirapuram Ghaziabad
TEL
9958657744
Homepage URL
pooja.ujn02@gmail.com
Sponsor or person
Institute
Laser Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Laser Eye Clinic, Noida
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GS Medical College
Address
Piplibandarpur
Tel
8076020248
dean@gsmedicalcollege.in
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
hod.ophthal@gsmedicalcollege.in
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 02 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069835
