UMIN-CTR Clinical Trial

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
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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
Email	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
Email	nabedosu@outlook.com

Sponsor
Institute	Minami Osaka Eye Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051035