UMIN-CTR Clinical Trial

Basic information
Public title	IOL calculation by ray tracing using ARGOS
Acronym	IOL calculation by ray tracing using ARGOS
Scientific Title	IOL calculation by ray tracing using ARGOS
Scientific Title:Acronym	IOL calculation by ray tracing using ARGOS
Region	Japan

Condition
Condition	Cataract (crystalline lens reconstructive operation by phacoemulsification)
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Most of the existing intraocular lens (hereinafter referred to as IOL) calculation formulas calculate the IOL power by approximating the cornea and IOL as one refraction plane, while the ray tracing method uses the front and back surfaces of the cornea, which calculate IOL power by thick optic model which treat front and back of IOL as curved surface, and is theoretically most accurate method to calculate IOL power. IOL power calculation requires axial length measurement, but conventional axial length measuring device calculates the axial length using the equivalent refractive index obtained from the average composition ratio of the intraocular component. On the other hand, SS-OCT biometer ARGOS calculates the axial length as the sum of values obtained by dividing the optical path length of each part of corneal thickness, aqueous humor, lens, and vitreous by the refractive index of each tissue, and it is known that the axial length can be more accurately calculated theoretically even with an eye with irregular ratio such as long or short axis. With the spread of premium IOL, more accurate IOL power calculation is being demanded, but IOL power calculation performed by the combination of ARGOS, which measures the axial length using the segmental refractive index, and the ray tracing method has not been reported yet. Therefore, we decided to study the predicted refraction error by calculating IOL power using ARGOS and ray tracing method.
Basic objectives2	Others
Basic objectives -Others	we decided to study the predicted refraction error by calculating IOL power using ARGOS and ray tracing method.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predicted refractive error calculated by each IOL calculation formula (ray tracing, SRK/T,Haigis,Barrett Universal II) Predicted refractive error: spherical equivalent difference between predicted refractive value and manifest refraction 1-3 months after surgery
Key secondary outcomes	1.Measurable rate(all eyes, nucleus hardness greater than 4) 2.Best corrected visual acuity 3.As subanalysis, axial length of eye is divided into groups (shorter than 22mm, 22-26mm, longer than 26mm) and predicted refractive error is compared

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
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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) 1 case/1 eye of patient who had crystalline lens reconstructive operation by phacoemulsification7 (2) Patient with SN60WF (AcrySof IQ) inserted and fixed in lenticular capsule. (3) Patient without opacity in optic media except for crystalline lens with cataract (4) Patient who can expect to obtain postoperative best corrected vision more than 0.8 (5) Patient who can be followed-up postoperatively
Key exclusion criteria	(1)Patient who is planning to have other ocular surgery within 3 months after cataract surgery (2)Patient who underwent ocular surgery such as uncontrolled glaucoma, progressive diabetic retinopathy, uveitis, retinal detachment, rubeosis iridis, pterygium, corneal dystrophy, corneal transplant, keratorefractive surgery, or with severe dry eye. (3)Corneal astigmatism more than 2.0D (4)Patient with ocular disease or takes medication which may affect visual acuity. (5)Patient who experienced Zinn's zonule rupture, posterior capsule rupture, vitreous prolapse, hyphema, and unable to completely fix IOL optic and haptics in lens capsule during surgery. (6)Patient who physician considers unsuitable due to systemic or ophthalmic disease
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Ichikawa
Organization	Chukyo Eye Clinic
Division name	Chukyo Eye Clinic
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Email	ichikawa@chukyogroup.jp

Public contact
Name of contact person	1st name Kazuo Middle name Last name Ichikawa
Organization	Chukyo Eye Clinic
Division name	Chukyo Eye Clinic
Zip code	456-0032
Address	12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
TEL	052-883-1543
Homepage URL
Email	ichikawa@chukyogroup.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	Alcon
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	12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi
Tel	052-883-1543
Email	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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 08 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
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 05 Month 11 Day
Date of IRB	2020 Year 05 Month 11 Day
Anticipated trial start date	2020 Year 05 Month 11 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	There is no additional test for this study, and all tests are routinely done before and after surgery as evaluation.

Management information
Registered date	2020 Year 06 Month 08 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046435

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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