UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040684 |
|---|---|
| Receipt number | R000046435 |
| Scientific Title | IOL calculation by ray tracing using ARGOS |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2023/02/22 11:51:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
IOL calculation by ray tracing using ARGOS
Acronym
IOL calculation by ray tracing using ARGOS
Scientific Title
IOL calculation by ray tracing using ARGOS
Scientific Title:Acronym
IOL calculation by ray tracing using ARGOS
Region
| Japan |
Condition
Condition
Cataract (crystalline lens reconstructive operation by phacoemulsification)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most of the existing intraocular lens (hereinafter referred to as IOL) calculation formulas calculate the IOL power by approximating the cornea and IOL as one refraction plane, while the ray tracing method uses the front and back surfaces of the cornea, which calculate IOL power by thick optic model which treat front and back of IOL as curved surface, and is theoretically most accurate method to calculate IOL power.
IOL power calculation requires axial length measurement, but conventional axial length measuring device calculates the axial length using the equivalent refractive index obtained from the average composition ratio of the intraocular component.
On the other hand, SS-OCT biometer ARGOS calculates the axial length as the sum of values obtained by dividing the optical path length of each part of corneal thickness, aqueous humor, lens, and vitreous by the refractive index of each tissue, and it is known that the axial length can be more accurately calculated theoretically even with an eye with irregular ratio such as long or short axis.
With the spread of premium IOL, more accurate IOL power calculation is being demanded, but IOL power calculation performed by the combination of ARGOS, which measures the axial length using the segmental refractive index, and the ray tracing method has not been reported yet. Therefore, we decided to study the predicted refraction error by calculating IOL power using ARGOS and ray tracing method.
Basic objectives2
Others
Basic objectives -Others
we decided to study the predicted refraction error by calculating IOL power using ARGOS and ray tracing method.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predicted refractive error calculated by each IOL calculation formula (ray tracing, SRK/T,Haigis,Barrett Universal II)
Predicted refractive error: spherical equivalent difference between predicted refractive value and manifest refraction 1-3 months after surgery
Key secondary outcomes
1.Measurable rate(all eyes, nucleus hardness greater than 4)
2.Best corrected visual acuity
3.As subanalysis, axial length of eye is divided into groups (shorter than 22mm, 22-26mm, longer than 26mm) and predicted refractive error is compared
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 1 case/1 eye of patient who had crystalline lens reconstructive operation by phacoemulsification7
(2) Patient with SN60WF (AcrySof IQ) inserted and fixed in lenticular capsule.
(3) Patient without opacity in optic media except for crystalline lens with cataract
(4) Patient who can expect to obtain postoperative best corrected vision more than 0.8
(5) Patient who can be followed-up postoperatively
Key exclusion criteria
(1)Patient who is planning to have other ocular surgery within 3 months after cataract surgery
(2)Patient who underwent ocular surgery such as uncontrolled glaucoma, progressive diabetic retinopathy, uveitis, retinal detachment, rubeosis iridis, pterygium, corneal dystrophy, corneal transplant, keratorefractive surgery, or with severe dry eye.
(3)Corneal astigmatism more than 2.0D
(4)Patient with ocular disease or takes medication which may affect visual acuity.
(5)Patient who experienced Zinn's zonule rupture, posterior capsule rupture, vitreous prolapse, hyphema, and unable to completely fix IOL optic and haptics in lens capsule during surgery.
(6)Patient who physician considers unsuitable due to systemic or ophthalmic disease
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Alcon
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Eye Clinic, REC
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
Tel
052-883-1543
rec@chukyogroup.jp
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
| 2020 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
568
Results
.
Results date posted
| 2023 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
.
Participant flow
.
Adverse events
none
Outcome measures
Predicted refractive error calculated by each IOL calculation formula (ray tracing, SRK/T,Haigis,Barrett Universal II)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no additional test for this study, and all tests are routinely done before and after surgery as evaluation.
Management information
Registered date
| 2020 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046435
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
