UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044686 |
|---|---|
| Receipt number | R000051037 |
| Scientific Title | Evaluation of predictive accuracy with monofocal IOL using ARGOS and ORA |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2021/06/28 14:58:27 |
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Basic information
Public title
Evaluation of predictive accuracy with monofocal IOL using ARGOS and ORA
Acronym
Evaluation of predictive accuracy with monofocal IOL using ARGOS and ORA
Scientific Title
Evaluation of predictive accuracy with monofocal IOL using ARGOS and ORA
Scientific Title:Acronym
Evaluation of predictive accuracy with monofocal IOL using ARGOS and ORA
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cataract surgery has begun to have an aspect of refractive surgery in recent years and higher accuracy of predicted refraction is called for. Along with this trend, the IOL power calculation formulas and the examination apparatuses have been advanced.
In the examination apparatuses, an apparatus using equivalent refractive index for measuring eye axial length that is the most important element to determine IOL power has been commonly used, but recently a newly developed axial length measuring apparatus (ARGOS) that uses a segmental refractive index was launched. In addition, the emergence of ORA that is an intraoperative wavefront aberration analysis system enables surgeons to intraoperatively validate the preoperative planned surgery in real time, and it becomes possible to predict the postoperative refraction multidirectionally.
Evaluations for the accuracy of postoperative refraction by axial length measuring biometer using equivalent refractive index or a combination of such biometer and ORA have been conducted. However, there have been few reports so far of the accuracy of postoperative refraction by ARGOS that uses segmental refractive index or a combination of ARGOS and ORA being evaluated.
We decided to conduct this study to compare ARGOS with OA2000 that is a conventional axial length measuring biometer, and to evaluate the accuracy of postoperative refraction by a combination of ARGOS and ORA.
Basic objectives2
Others
Basic objectives -Others
To compare the accuracy of postoperative refraction by ARGOS, OA2000, ARGOS with ORA, and OA2000 with ORA in patients with Clareon IOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Refractive prediction error, absolute refractive prediction error, and rate (within 0.25D, within 0.5D, within 0.75D, and within 1.0D) of absolute value on ARGOS, OA2000, combination of ARGOS and ORA, and combination of OA2000 and ORA.
Key secondary outcomes
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients between 20 and 85 years of age who are scheduled to undergo lens reconstruction by lens phacoemulsification aspiration. Gender is not required.
(2) Patients with Clareon IOL inserted in the capsular bag
(3) Postoperative Best Corrected Distance visual acuity (BCDVA) of 0.8 decimal or better in study eye
(4) Patients who have the data of examination and observation criteria
(5) Patients who have performed intraoperative refractive biometry measurement with ORA
Key exclusion criteria
(1) Patients with the experience of ocular surgery other than cataract surgery within 3 months after cataract surgery
(2) Patient with uncontrolled glaucoma, progressive diabetes, retinal disorders and severe dry eye.
(3) Corneal astigmatism more than 1.25D
(4) Patients with a disease possibly affecting the visual acuity or patients receiving medication possibly affecting the visual acuity
(5) Patients found during surgery to have laceration of zonule of Zinn, posterior capsule rupture, vitreous loss, hyphema or inability to implant the IOL in the capsular bag completely.
(6) Disqualified by the investigator or the sub investigator because of systemic or ophthalmic diseases
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Watanabe |
Organization
Minami Osaaka Eye Clinic
Division name
Minami Osaka Eye Clinic
Zip code
590-0402
Address
3-174-6, Okubokita, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-1750
nabedosu@outlook.com
Public contact
Name of contact person
| 1st name | Keizo |
| Middle name | |
| Last name | Watanabe |
Organization
Minami Osaka Eye Clinic
Division name
Minami Osaka Eye Clinic
Zip code
590-0402
Address
3-174-6, Okubokita, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-1750
Homepage URL
nabedosu@outlook.com
Sponsor or person
Institute
Minami Osaka 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
NPO MINS
Address
1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2021 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observation Study.
Information from patients who visited the study site between January 2021 and January 2022 and who met the exclusion criteria will be included.
Information to be included will be gender, age, comorbidities, treatment, visual acuity, biometry and refraction tests.
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051037
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