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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040684 |
Receipt No. | R000046435 |
Scientific Title | IOL calculation by ray tracing using ARGOS |
Date of disclosure of the study information | 2020/06/08 |
Last modified on | 2020/06/08 |
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 |
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Condition | ||
Condition | Cataract (crystalline lens reconstructive operation by phacoemulsification) | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ichikawa@chukyogroup.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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 |
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Last modified on |
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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 |