UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017727
Receipt No. R000020520
Scientific Title Corrected VA with Long Term Follow up after AcrySof IOL Implantation
Date of disclosure of the study information 2015/06/01
Last modified on 2016/11/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Corrected VA with Long Term Follow up
after AcrySof IOL Implantation
Acronym Corrected VA with Long Term Follow up
after AcrySof IOL Implantation
Scientific Title Corrected VA with Long Term Follow up
after AcrySof IOL Implantation
Scientific Title:Acronym Corrected VA with Long Term Follow up
after AcrySof IOL Implantation
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate non-inferiority of AcrySof (acrylic) to control IOLs (silicone and PMMA) in BCVA change at the long-term post-implantation (implantation period is 1994 to 2000) visit.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BCVA change at the long term post implantation visit from within 3 months after IOL implantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 AcrySof group
Interventions/Control_2 PMMA group
Interventions/Control_3 Slicone group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Willing to provide voluntary consent and able to comprehend and sign the informed consent form
2)Pseudophakic patients who were implanted with an Acrylic (AcrySof), PMMA or silicone IOL from 1994 to 2000.
3)Clear intraocular media in study eyes
4)Best corrected visual acuity (decimal) within 3 months post implantation is 0.8 (decimal VA chart) or more in study eye.
5)Patient who does not have an ocular or systemic condition which may affect visual acuity in study eye.
Key exclusion criteria 1)Patient who has the following complications that may have an impact on visual acuity at the time of the prospective visit in study eye.
-Glaucoma
-Diabetic retinitis
-Ocular inflammatory disease; scleritis, uveitis, herpes corneae, etc.
-Retinal detachment
-Abnormal retina and fovea; Macular degeneration, retinal disease
-Corneal disease, corneal endothelial cell loss, etc.
-History of keratoplasty
-Ocular trauma
-Intraocular surgery post IOL implantation Occur with post capsular Opacification. Eyes that had YAG laser performed or with peripheral opacification (outside the photopic pupil size) will be allowed in the study
2)Previous refractive surgery in study eye
3)Previous IOL exchange in study eye
4)Disqualified by the investigator or the sub investigator because of systemic or ophthalmic diseases
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Miyata
Organization Miyata Eye Hospital
Division name Miyata Eye Hospital
Zip code
Address 6-3 Kurahara Miyakonojo Miyazaki
TEL 0986-22-1441
Email miyata@miyata-med.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hasegawa
Organization Alcon Japan Ltd.
Division name Clinical Development, Clinical & Regulatory Affairs
Zip code
Address 1-23-1 Toranomon, Minato-ku, Tokyo
TEL 03-6899-5061
Homepage URL
Email koji.hasegawa@alcon.com

Sponsor
Institute Alcon Japan Ltd.
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
Address
Tel
Email

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
2015 Year 06 Month 01 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 The mean change in logMAR best-corrected visual acuity from baseline at the long-term post-implantation follow-up visit was 0.01, 0.04, and -0.01 in the AcrySof, silicone, and PMMA groups, respectively. The upper limit of 97.5% one-sided confidence interval of the difference in the change in best-corrected visual acuity between the AcrySof group and each control group was +0.01 logMAR for the silicone group and +0.07 logMAR for the PMMA group, both of which were lower than the non-inferiority margin of +0.1 logMAR.
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 Completed
Date of protocol fixation
2015 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective adverse events were observed in the target eye for efficacy analysis of 1 subject (3.2%) in the AcrySof group and in the contralateral eye of 1 subject (3.3%) in the PMMA group. None of these events were considered to be related to the IOL.
Retrospective adverse events were observed in 1 subject (3.2%) in the AcrySof group, 3 subjects (8.1%) in the silicone group, and 4 subjects (13.3%) in the PMMA group. None of these events were considered to be related to the IOL.
A retrospective adverse reaction was observed in 1 subject (2.7%) in the silicone group. The causal relationship between this event and the IOL was considered unknown by the investigator, and the event was therefore classified as an adverse reaction.
No device failures were observed.

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.