UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044685 |
|---|---|
| Receipt number | R000051035 |
| Scientific Title | Predictive Refraction Accuracy of the ORA Intraoperative Wavefront Aberration Analyzer for PanOptix (non-Toric) and PanOptix Toric |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2021/06/28 14:55:48 |
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Basic information
Public title
Predictive Refractive Accuracy of Intraoperative Wavefront Aberration Analyzer for Trifocal IOLs
Acronym
Predictive Refractive Accuracy of Intraoperative Wavefront Aberration Analyzer for Trifocal IOLs
Scientific Title
Predictive Refraction Accuracy of the ORA Intraoperative Wavefront Aberration Analyzer for PanOptix (non-Toric) and PanOptix Toric
Scientific Title:Acronym
Predictive Refraction Accuracy of the ORA Intraoperative Wavefront Aberration Analyzer for PanOptix (non-Toric) and PanOptix Toric
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, cataract surgery has made remarkable progress, and expectations of patients have been growing for the surgery. The patients especially have higher expectations for Premium IOLs in terms of its property and those need higher accuracy of the preoperative examination and the IOL power calculation.
ORA, an intraoperative wavefront aberrometry, enables surgeons to measure the refraction in the aphakic phase and determine the IOL power intraoperatively, and ORA has been reported that it has the same or higher accuracy of predicted postoperative refraction as the preoperative IOL power formulas. On the other hand, PanOptix is the first approved trifocal intraocular lens in Japan, and it is reported that PanOptix shows good visual performance and satisfaction. Although further improvements in accuracy and satisfaction can be expected by using ORA, there is few reports to have assessed the predictive accuracy of ORA with PanOptix.
Not only spherical equivalent refractive errors but also residual astigmatism highly influence on the postoperative satisfactions. We have experienced some cases, in which the preoperative examination indicated the adaption of non-Toric IOL but the residual astigmatism remained after the surgery, and Toric IOL should have been inserted. Thus, it is desirable to be able to choose Toric or non-Toric and determine the cylindrical power of Toric IOL before the IOL insertion. Therefore, we decided to conduct a retrospective study to compare ORA with the preoperative IOL power calculation formulas in the predictive accuracy for PanOptix and PanOptix Toric, and also to investigate correlation between the postoperative residual astigmatism and each factor.
Basic objectives2
Others
Basic objectives -Others
The predictive refractive accuracy of ORA for PanOptix (non-Toric) and PanOptix Toric will be evaluated in comparison to preoperative IOL power calculations. In addition, factors associated with postoperative residual astigmatism will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORA and preoperative IOL power formula and the equivalent spherical power of subjective refraction at 1 to 3 months postoperatively
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have underwent cataract surgery by phacoemulsification in Minami Osaka Eye Clinic and have the data of examination and observation criteria
(2) Patients with PanOptix or PanOptix Toric inserted in the capsular bag
(3) Postoperative Best Corrected Distance visual acuity (BCDVA) of 1.0 decimal or better in study eye
(4) Patients who have performed intraoperative refractive biometry measurement with ORA
(5) The age of 20 and more
Key exclusion criteria
(1) Patients with the experience of ocular surgery other than cataract surgery within 3 months after cataract surgery
(2) Patients with corneal lesion affecting the measurement of ORA during surgery
(3) Patients where ORA measurement was poor
(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
180
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Watanabe |
Organization
Minami Osaka Eye Clinic
Division name
Minami Osaka Eye Clinic
Zip code
5900402
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
5900402
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
180
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective single center observational study.
Information from patients who received the study site between July 2019 and December 2020 and met the selection exclusion criteria will be included.
The information to be included will be gender, age, comorbidities, treatment details, visual acuity test, biometric test, and refraction test.Retrospective single center observational study.
Information from patients who received the study site between July 2019 and December 2020 and met the selection exclusion criteria will be included.
The information to be included will be gender, age, comorbidities, treatment details, visual acuity test, biometric test, and refraction test.
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=R000051035
