UMIN-CTR Clinical Trial

Public title

A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients

Acronym

A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients

Scientific Title

A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients

Scientific Title:Acronym

A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients

Region

Japan

Condition

Emmetropic presbyopes

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the application of the AcuFocus(TM) Corneal Inlay (ACI) implanted intra-stromally in emmetropic presbyopes for the improvement of near vision.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Uncollected distance visual acuity and uncollected near visual acuity

Key secondary outcomes

Patient satisfaction
Safety

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

40

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

Emmetropic presbyopes who have provided informed consent for ACI implantation, and meet all the following criteria:
1. Emmetropes needing a magnitude of +0.75D to +2.50D of reading glasses
2. Distance visual acuity correctable to at least 0.8 in both eyes
3. Preoperative spherical equivalent of plano defined as +0.50D to -1.25D with no more than 0.75D of refractive cylinder in the eye to be implanted
4. Must discontinue their soft contact lenses for at least one week prior to ACI pre-operative examination
5. Minimum central corneal thickness of >= 500 microns in the eye to be implanted.
6. Corneal power of >= 39.00D and <= 49.00D in all meridians in the eye to be implanted
7. Endothelial cell count >= 2000 cells/mm2 in the eye to be implanted
8. Able to return for scheduled follow-up examinations for 12 months after surgery
9. Written informed consent given.

Key exclusion criteria

1. Active or recurrent ocular pathology, including eyelid disease, corneal abnormalities (e.g. keratoconus, endothelial dystrophy), cataracts, glaucoma, ocular hypertension, macular degeneration, retinal detachment or any other ocular pathology that would prevent an acceptable visual outcome in the eye to be implanted
2. With a history of steroid-responsive rise in intraocular pressure.
3. Dry eye as determined by objective testing.
4. Using systemic medications with significant ocular side effects, including medications known to exacerbate or induce moderate to severe dry eye.
5. Abnormal threshold visual field.
6. With a history of herpes zoster or herpes simplex keratitis.
7. With a history of diagnosed diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
8. Chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised patients.
9. Using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
10. Sensitivity to planned study concomitant medications.

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Kanjiro Masuda

Organization

Masuda memorial eye care clinic

Division name

Director

Zip code

Address

5F Tsutsumi Bldg. 1-13-12, Shinbashi Minato-ku Tokyo, Japan, 105-0004

TEL

03-3593-0381

Email

Name of contact person

1st name
Middle name
Last name	Hiroshi Morifuji

Organization

Mebix, Inc.

Division name

The 3rd Research Promotion Group

Zip code

Address

1-3-25, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-5842-3901

Homepage URL

Email

Institute

Japanese Research Center of Refractive
Surgery

Institute

Department

Personal name

Organization

Japanese Research Center of Refractive Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2009

Year

05

Month

25

Day

Date of IRB

Anticipated trial start date

2009

Year

06

Month

01

Day

Last follow-up date

2012

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Objective: To evaluate the application of the AcuFocus(TM) Corneal Inlay (ACI) implanted intra-stromally in emmetropic presbyopes for the improvement of near vision.

Registered date

2009

Year

06

Month

29

Day

Last modified on

2009

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002607