Condition category
Eye Diseases
Date applied
09/07/2018
Date assigned
20/07/2018
Last edited
18/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cataracts are a disease in which the lens of the eye becomes cloudy. This can be caused by age. Astigmatism is a condition where vision may be blurred as a result of an error of the lens. Patients with both cataracts and astigmatism often undergo surgery where an ordinary intraocular lens is inserted. This fixes cataracts, but does not correct astigmatism and therefore patients may still have poor vision.
To correct both astigmatism and cataracts, a type of lens called a toric intraocular lens can be inserted. It is important to insert the toric intraocular lens in the correct axis (the position of the astigmatism) in order to effectively correct the astigmatism.
There are two methods of indicating, or marking, the axis of lens implantation - either using a machine-based method, or manually by the surgeon performing the operation. We aimed to determine which of these methods is more effective.

Who can participate?
Adults with cataracts and corneal astigmatism

What does the study involve?
Participants will undergo lens implantation cataract surgery, and will be randomly allocated to receive this surgery either using a machine or from a surgeon and will receive follow up tests 1 day, 1 month and 2 months after the surgery. Additionally, participants will be tested for uncorrected and best corrected visual acuity before and 1 day, 1 month and 2 months after the surgery.

What are the possible benefits and risks of participating?
The benefit to participants of taking part is that their cataracts will be removed and their astigmatism will be corrected. A possible risk of taking part is complications from cataract surgery, such as infection.

Where is the study run from?
St Mary's Hospital, Seoul, South Korea

When is the study starting and how long is it expected to run for?
February 2014 to April 2018

Who is funding the study?
1. Korean Health Technology R&D Project (South Korea)
2. Ministry for Health & Welfare, Republic of Korea (South Korea)
3. National Research Foundation of Korea (NRF) (South Korea)

Who is the main contact?
Dr Rowoon Yi
beneficialyi@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Choun-Ki Joo

ORCID ID

Contact details

Department of Ophthalmology
The Catholic University of Korea
Seoul St. Mary’s Hospital
#222 Banpo-daero
Seocho-gu
Seoul 137-701
Korea
Seoul
137701
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Accuracy of Toric Intraocular Lens implantation using Automated Vs Manual Marking

Acronym

N/A

Study hypothesis

The SensoMotoric Instruments (SMI) is more accurate than manual marking for Toric IOL implantation during cataract surgery.

Ethics approval

Institutional review board of Bucheon St. Mary’s Hospital, 02/01/2014, HC14RISI0077

Study design

Prospective interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Cataracts with corneal astigmatism

Intervention

Participants will be randomised to either SMI group or manual group in a 1:1 allocation using individual-level blocked randomisation stratified by sex (male, female) and age. The randomisation sequence will be computer-generated by the trial statistician and programmed by the data manager.
The SMI group will undergo toric intraocular lens implantation using SMI (SensorMotoric Instruments) marking, whereas the manual group will undergo toric intraocular lens implantation using manual marking (done by a surgeon).
Before and after lens implantation, participants were tested for uncorrected visual acuity, best corrected visual acuity and corneal topography.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Toric intraocular axis, measured using a refractometer 1 day, 1 month and 2 months post-operation

Secondary outcome measures

The following are measured by a physician using the logMAR method 1 day, 1 month and 2 months post-operation:
1. Uncorrected visual acuity
2. Best corrected visual acuity

Overall trial start date

01/02/2014

Overall trial end date

01/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Cataracts
2. Corneal astigmatism > 1.5 diopters
3. Aged over 20

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Glaucoma
2. Retinal disease
3. Irregular astigmatism

Recruitment start date

01/02/2014

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Korea, South

Trial participating centre

Seoul St. Mary’s Hospital
Department of Ophthalmology, The Catholic University of Korea, Seoul St. Mary’s Hospital, #222 Banpo-daero, Seocho-gu, Seoul 137-701, Korea
Seoul
137701
Korea, South

Sponsor information

Organisation

Ministry for Health & Welfare, Republic of Korea

Sponsor details

13
Doum 4-ro
Sejong-si
Republic of Korea
Seoul
30113
Korea
South
82-44-202-2118
admin@mohw.go.kr

Sponsor type

Government

Website

http://www.mohw.go.kr/eng/index.jsp

Funders

Funder type

Not defined

Funder name

Ministry for Health & Welfare, Republic of Korea

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish in BMC Ophthalmology in 2018

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rowoon Yi (beneficialyi@gmail.com). The data available will be individual participant data that underlies the results reported after deidentification (text, tables, figures and appendices), along with the study protocol. Data will be available from 9 months after until 36 months after article publication and will be shared with investigators whose proposed use of the data has been approved by an independent review committee. Data provided may be used for individual participant meta-analysis. Proposals should be directed to beneficialyi@gmail.com(Rowoon Yi, clinical fellow) to gain access and data requestors will need to sign a data access agreement.

Intention to publish date

01/09/2018

Participant level data

Available on request

Basic results (scientific)

The steep axis may be measured differently using SensoMotoric Instruments(SMI) and manual marking. The SMI is more accurate than manual marking for Toric IOL implantation during cataract surgery.

Publication list

Publication citations

Additional files

Editorial Notes