UMIN-CTR Clinical Trial

Public title

Clinical outcomes of posterior chamber phakic intraocular lens with hole in LASIK eyes

Acronym

ICL surgery for LASIK eyes

Scientific Title

Clinical outcomes of posterior chamber phakic intraocular lens with hole in LASIK eyes

Scientific Title:Acronym

ICL surgery for LASIK eyes

Region

Japan

Condition

Myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Hole ICL insertion is safe and effective, and has been introduced in more than 130 facilities in Japan, and in recent years, it has increased to about 40% of all refractive surgeries (more than 10,000 eyes per year). In the 7th edition of the Guidelines for Refractive Surgery by the Japan Ophthalmological Society, revised in 2019, it was changed to cautious application for myopia of -6D or less, which was previously not applicable. It is highly likely that it will continue to be popular in the future from the perspective of superior visual function compared to other refractive surgeries.

LASIK was reported by Pallikaris et al. in 1990, and in Japan, it is a standard procedure for refractive surgery, with 450,000 cases per year at its peak in 2008, and has recently decreased to about 40,000 cases in 2022, but is performed about 800,000 times per year in the United States and Europe. There are many reports of good clinical outcomes, but one of the problems is regression over the long term. Ikeda et al. reported that about 10% of patients re-myopia 12 years after surgery, and 18% require additional treatment.
With the revised guidelines, it is expected that ICL will increasingly be chosen as a correction method after LASIK. There have only been a single report both in Japan and overseas on the use of Hole ICL as additional correction after LASIK. As one of Japan's leading ICL surgery facilities, this study has many opportunities to perform Hole ICL surgery as additional correction on eyes after LASIK, and the significance of reporting a large number of cases from a single facility is great, and it is believed to be highly significant as an educational activity to properly educate patients about ICL insertion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visual acuity and fully corrected refractive index before and after surgery in patients who underwent Hole ICL implantation surgery

Key secondary outcomes

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

18

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who have previously undergone LASIK surgery and have relapsed into myopia, and wish to undergo revision surgery using ICL

Key exclusion criteria

Patients with eye diseases other than refractive errors, and patients who cannot consent to surgery

Target sample size

70

Name of lead principal investigator

1st name	Masahide
Middle name
Last name	Takahashi

Organization

Sanno Hospital

Division name

Ophthalmology

Zip code

1070052

Address

8-10-16 Akasaka, Minato-ku, Tokyo

TEL

0334023151

Email

m-hide@iuhw.ac.jp

Name of contact person

1st name	Masahide
Middle name
Last name	Takahashi

Organization

Sanno Hospital

Division name

Ophthalmology

Zip code

1070052

Address

8-10-16 Akasaka, Minato-ku, Tokyo

TEL

0334023151

Homepage URL

Email

m-hide@iuhw.ac.jp

Institute

Sanno Hospital

Institute

Department

Personal name

Organization

Sanno Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Junwakai IRB

Address

8-10-16 Akasaka, Minato-ku, Tokyo

Tel

0334023141

Email

m-hide@iuhw.ac.jp

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

2024

Year

07

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

Preinitiation

Date of protocol fixation

2024

Year

07

Month

29

Day

Date of IRB

Anticipated trial start date

2024

Year

07

Month

29

Day

Last follow-up date

2024

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

As this is a retrospective, non-interventional study, and no tests beyond those performed in regular medical practice will be conducted, information will be made available to participants by displaying posters in our eye center, with the opportunity to refuse. As participants are instructed to visit our hospital regularly after ICL surgery, this information can be made known to the participants.

Registered date

2024

Year

07

Month

24

Day

Last modified on

2024

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062906