UMIN-CTR Clinical Trial

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
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	590-0402
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051037