UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Corrected VA with Long Term Follow up after AcrySof IOL Implantation
Title of the study (Brief title)	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	Kazunori Miyata
Organization	Miyata Eye Hospital
Division name	Miyata Eye Hospital
Address	6-3 Kurahara Miyakonojo Miyazaki
TEL	0986-22-1441
Email	miyata@miyata-med.ne.jp

Public contact
Name of contact person	Koji Hasegawa
Organization	Alcon Japan Ltd.
Division name	Clinical Development, Clinical & Regulatory Affairs
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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