UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043202 |
|---|---|
| Receipt number | R000049306 |
| Scientific Title | Study of predicted refraction error after cataract surgery using ARGOS in long and short axial length |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/08/02 16:49:57 |
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Basic information
Public title
Study of predicted refraction error after cataract surgery using ARGOS in long and short axial length
Acronym
Study of predicted refraction error of ARGOS in long and short axial length
Scientific Title
Study of predicted refraction error after cataract surgery using ARGOS in long and short axial length
Scientific Title:Acronym
Study of predicted refraction error of ARGOS in long and short axial length
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The axial length measuring device, which is currently regarded as the gold standard, calculates the axial length using the equivalent refractive index obtained from the average constituent ratio of the intraocular constituent parts. On the other hand, ARGOS, an SS-OCT biometer, calculates the axial length as the sum of the values obtained by dividing the optical path length of each part of the cornea, aqueous humor, crystalline lens, and vitreous body by the refractive index (divisional refractive index) of each tissue.
The conventional intraocular lens (hereinafter, IOL) power calculation formula has been corrected or modified by using the axial length using the equivalent refractive index, and the accuracy of the IOL power calculation formula has increased, there is still a problem of accuracy for irregular eyes such as long-eye axis and short-eye axis. In addition, the accuracy of IOL power calculation by ARGOS using the differential refractive index in the long-eye axis eye and the short-eye axis eye has only been reported in a limited number of cases, and no reports have been made on the optimization of IOL constants in ARGOS.
Therefore, this time, we collected many cases of long-eye axis and short-eye axis, examined the accuracy of IOL power calculation using ARGOS, and decided to optimize the IOL constant in ARGOS.
Basic objectives2
Others
Basic objectives -Others
It was decided to evaluate the predicted refraction error in the cases of the long and short eye axes. In addition, it was decided to examine the optimum intraocular lens constant.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predicted refraction error (difference between predicted refraction value and equivalent spherical value 1 to 3 months after surgery) calculated by SRK / T, Haigis and Barret Universal II for long axis (26 mm or more) and short axis (22 mm or less)
Key secondary outcomes
1. Best corrected vision
2. Biometric values (axial length, corneal refractive power, corneal thickness, anterior chamber depth, corneal lateral diameter)
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) One eye of a patient who underwent lens reconstruction by lens emulsification and aspiration between September 2017 and September 2020
(2) Patients who were able to implant and fix SN60WF (Alcon) in the lens capsule
(3) Patients with best corrected visual acuity of 0.8 or more 1 to 3 months after surgery
(4) Patients with data on examination / observation items
(5) Patients with preoperative axial length of 22 mm or less or 26 mm or more
Key exclusion criteria
(1) Patients who underwent other eye surgery within 3 months after cataract surgery
(2) Patients with uncontrolled glaucoma, progressive diabetic retinopathy, uveitis, retinal detachment, iris angiogenesis, corneal degeneration, history of eye surgery including corneal transplantation and corneal refractive surgery, and severe dry eye
(3) Corneal astigmatism is 2.0D or higher
(4) Patients with diseases that may affect eyesight, or patients who have used drugs that may affect eyesight
(5) Patients with Zinn's zonule rupture, posterior capsule breakage, vitreous prolapse, hyphema, and IOL haptics that could not be completely fixed in the lens capsule during surgery
(6) Patients who the doctor deems inappropriate because of systemic or ophthalmic diseases.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Isanakai Medical Corporation Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Isanakai Medical Corporation Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city Aichi
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Isanakai Medical Corporation Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd
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
12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya city Aichi
Tel
052-884-7976
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
医療法人いさな会 中京眼科（愛知県）
独立行政法人地域医療機能推進機構 中京病院（愛知県）
医療法人桑友会 佐藤裕也眼科医院（宮城県）
医療法人涼悠会 トメモリ眼科・形成外科（和歌山県）
南大阪アイクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
128
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
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study. Patients who visited the study facility from September 2017 to October 2020 and who met the inclusion criteria and did not meet the exclusion criteria are included.
The subject information is gender, age, complications, treatment details, visual acuity test, biometric test, and refraction test.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049306
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| Registered date | File name |
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