UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029860
Receipt number R000034104
Scientific Title Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses
Date of disclosure of the study information 2017/11/07
Last modified on 2018/11/08 11:16:57

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Basic information

Public title

Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses

Acronym

Efficacy of multifocal contact lens for eye after Efficacy of multifocal contact lens after implantation of monofocal intraocular lenses

Scientific Title

Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses

Scientific Title:Acronym

Efficacy of multifocal contact lens for eye after Efficacy of multifocal contact lens after implantation of monofocal intraocular lenses

Region

Japan


Condition

Condition

Pseudophakic eyes with monofocal intraocular lenses

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Alcon multifocal contact lens wear on monofocal intraocular lens implanted eyes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Distance, near and all distance visual acuities 1 and 3 months after multifocal contact lens wearing

Key secondary outcomes

Binocular Contrast sensitivity


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


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Patients who has monofocal IOL implanted the capsule due to cataract surgery aged over 20 years and under 70.
(2) Patients who wear SCL habitual current or used to before cataract surgery
(3) Patients whose calculated power of bifocal SCL will be within the test CL power.
(4) Patients with distance corrective vision is 0.8 or over
(5) Patients who willing to be available for the follow-up observation after SCL prescription.

Note: It is advised to consider carefully for the adaption of the below patients
(1) Who has a refractive surgery history of LASIK, PRK, LRI and so on.
(2) Corneal endothelial cell density if less than 1,500/mm2
(3) Glaucoma
(4) History of uveitis or retinal detachment
(5) Diabetic retinopathy
(6) Excessive myopia
(7) Congenital eyelid abnormality
(8) Zinn's zonule rupture
(9) Case of mild secondary cataract

Key exclusion criteria

(1) Infectious diseases, inflammation, abnormalities in the anterior ocular segment, diseases contraindicated for CL wearing
(2) Manifest astigmatism over 1.75D
(3) Toric IOL, multifocal IOL implanted eye
(4) Serious postoperative complications
(5) Poorly controlled glaucoma, progressive diabetic retinopathy, active uveitis
(6) Implanted multifocal IOL in one eye
(7) In addition, patients who is judged inappropriate due to systemic or ophthalmologic diseases by an investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Miyata, MD, PhD

Organization

Miyata Eye Hospital

Division name

Ophthalmology

Zip code


Address

6-3 Kurahara-cho, Miyakonojo

TEL

0986-22-1441

Email

kmiyata@miyata-med.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Miyata, MD, PhD

Organization

Miyata Eye Hospital

Division name

Ophthalmology

Zip code


Address

6-3 Kurahara-cho, Miyakonojo

TEL

0986-22-1441

Homepage URL


Email

kmiyata@miyata-med.ne.jp


Sponsor or person

Institute

Miyata Eye Hospital

Institute

Department

Personal name



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


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

2017 Year 11 Month 07 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

Completed

Date of protocol fixation

2017 Year 10 Month 14 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Design: cohort study
Recruiting: patients who visit the hospital between October and December, 2017 and meet the inclusion criteria.


Management information

Registered date

2017 Year 11 Month 07 Day

Last modified on

2018 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name