UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000039844 |
| Receipt No. | R000045427 |
| Scientific Title | Comparison of changes in refractive prediction error after cataract surgery among eyes that received three types of single-piece acrylic intraocular lenses: a single-blinded randomized parallel comparative study |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2020/03/17 (Ver. 1) |
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| Basic information | ||
| Public title | Changes in Refractive Prediction Error After Cataract Surgery in Eyes That Received Three Types of Single-Piece Acrylic Intraocular Lenses | |
| Acronym | Refractive prediction error with single-piece intraocular lens | |
| Scientific Title | Comparison of changes in refractive prediction error after cataract surgery among eyes that received three types of single-piece acrylic intraocular lenses: a single-blinded randomized parallel comparative study | |
| Scientific Title:Acronym | Single-blinded randomized comparison of changes in prediction error among eyes that received three types of single-piece acrylic intraocular lenses | |
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| Condition | ||
| Condition | cataract | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The purpose of this study was to compare early changes in refractive prediction error after cataract surgery among eyes that received 3 types of single-piece acrylic intraocular lenses |
| Basic objectives2 | Others |
| Basic objectives -Others | The purpose of this study was to compare changes in refractive prediction error (PE) after cataract surgery among eyes that received 3 types of single-piece acrylic intraocular lenses. We examined clinically relevant difference of 3 types of single-piece acrylic IOLs. |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Refractive prediction error (PE), and changes in PE was examined at 1 days, and 1 and 2 months postoperatively, and were compared among 3 IOL groups. |
| Key secondary outcomes | To clarify the causes why did the changes in PE during 2 months after surgery differ among these IOLs, we examined the factors that significantly affect the changes in PE |
| Base | |
| Study type | Observational |
| Study design | |
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| Randomization | |
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| Blinding | |
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| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Eligibility | ||||
| Age-lower limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | One-hundreds and ninety-five eyes of 195 patients who were scheduled to underwent cataract surgery and implantation of single-piece acrylic IOL was enrolled in this study. | |||
| Key exclusion criteria | Exclusion criteria were eyes with corneal disorders; eyes with vitreous opacity or retinal disease; eyes with ocular surface dryness; eyes scheduled for extracapsular or intracapsular cataract extraction; history of ocular surgery or inflammation; eyes with pseudoexfoliation; eyes with a pupil diameter < 4.0 mm after mydriasis; eyes with marked irregular corneal astigmatism; eyes with patient refusal; and any anticipated difficulties with examination or 2-months follow-up. | |||
| Target sample size | 195 | |||
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| Organization | Hayashi Eye Hospital | ||||||
| Division name | Department of ophthalmology | ||||||
| Zip code | 812-0011 | ||||||
| Address | 4-23-35, Hakataekimae, Hakata-ku, Fukuoka-city, Japan | ||||||
| TEL | 092-431-1680 | ||||||
| hayashi-ken@hayashi.or.jp | |||||||
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| Organization | Hayashi Eye Hospital | ||||||
| Division name | Department of ophthalmology | ||||||
| Zip code | 812-0011 | ||||||
| Address | 4-23-35, Hakataekimae, Hakata-ku, Fukuoka-city, Japan | ||||||
| TEL | 092-431-1680 | ||||||
| Homepage URL | |||||||
| hayashi-ken@hayashi.or.jp | |||||||
| Sponsor | |
| Institute | Hayashi Eye Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Hayashi Eye Hospital |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | None |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Institutional Review Board of Hayashi Eye Hospital |
| Address | 4-23-35, Hakataekimae, Hakata-ku, Fukuoka-city, Japan |
| Tel | 092-431-1680 |
| mihara-seiya@hayashi.or.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 | 林眼科病院（福岡県）/Hayashi Eye Hospital(Fukuoka) |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | None |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | None | ||||||
| Number of participants that the trial has enrolled | 195 | ||||||
| Results | The mean PE did not differ significantly among groups at 1 days and 1 month postoperatively, and were significantly less in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P<.0006). The mean change in PE between 1 day and 2 months after surgery was significantly less in the SN60WF group than in the other groups (P=.0062). |
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| Baseline Characteristics | One-hundred and ninety-five eyes of 195 patients were enrolled. |
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| Participant flow | After 195 patients were enrolled, 3 patients were lost to follow-up. data of 192 eyes remained in the analysis. |
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| Adverse events | None |
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| Outcome measures | Manifest spherical equivalent value (MRSE), PE, and changes in PE at 1day, and 1 and 2 months after surgery |
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| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | It is well known that refractive states change toward myopia immediately or early after cataract surgery. In this study, the results showed that the postoperative refraction and prediction error (PE) differ significantly among the 3 types of single-piece acrylic IOLs; they were less with the SN60WF compared with the XY-1 and ZCB00V. Changes in PE during 2 months was also less with the SN60WF than with the other IOLs, suggesting that postoperative refractive stability differ even among single-piece acrylic IOLs. |
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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=R000045427 |
