Condition category
Eye Diseases
Date applied
06/02/2018
Date assigned
14/02/2018
Last edited
12/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In cataract surgery, the lens inside the eye that has become cloudy due to cataracts is removed and replace with an artificial lens. These lens are called intraocular lens (IOL) and they make the vision clear. Sometimes after cataract surgery, people develop a thickening of the back of the lens called opacification. This may lead to complications. For these reasons, preventing opacification is very important and there is many different design of IOLs in worldwide for this purpose. This study aims to investigate the effect of the number and position of IOLs after implantation of three different designs of IOLs.

Who can participate?
Adults aged 55 to 75 years old who have a cataract.

What does the study involve?
Participants are randomly allocated to one of three groups as to which type of intraocular lens (IOL) during cataract surgery. Those in the first group receive the Ophtec Precison. Those in the second group receive the Lucid Korea Microflex. Those in the last group receive the Carl Zeiss Asphina. The same surgeon performs all the cataract surgeries using a standard procedure. At week one, two and six months after the procedure the participants are followed up to assess how their procedures went.

What are the possible benefits and risks of participating?
The three IOLs used in this study are intraocular lenses that have been proven safe and approved by the KFDA in Korea. The products that have already proven the safety of intraocular lenses are unlikely to cause additional risk or benefits to patients.

Where is the study run from?
Seoul St. Mary’s Hospital (South Korea)

When is the study starting and how long is it expected to run for?
August 2016 to December 2016

Who is funding the study?
Investigator initiated and funded (South Korea)

Who is the main contact?
Professor Choun-ki Joo (Scientific)
ckjoo@catholic.ac.kr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Choun-ki Joo

ORCID ID

http://orcid.org/0000-0003-0535-4118

Contact details

Seoul St. Mary’s Hospital
222
Banpo-daero
Seocho-gu
Republic of Korea
Seoul
06591
Korea
South
+82 02 2258 6329
ckjoo@catholic.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KC18RESI0081

Study information

Scientific title

Effect of number and position of intraocular lens haptics on anterior capsule contraction: A randomised, prospective trial

Acronym

Study hypothesis

The number and position of IOL haptics might affect anterior capsular contraction. The present study evaluates the capsulorhexis aperture after implantation of three differently designed intraocular lens.

Ethics approval

Ethics Committee of the Seoul St. Mary’s Hospital Korea, 05/02/2016, ref: KC18RESI0081

Study design

This was a prospective, randomized study of patients who were to undergo cataract surgery at Seoul St. Mary’s Hospital, Seoul, South Korea, between August 2016 and December 2016.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patient who have age related cataract in Seoul St.Mary's hospital.

Intervention

Participants who diagnosed senile cataractare included in this study. Nne of the following three randomly assigned IOLs was implanted during each patient’s cataract surgery: Precizon IOL (OPHTEC; IOL A), Microflex IOL (Lucid Korea Inc.; IOL B), and CT Asphina 509M IOL (Carl Zeiss; IOL C). Before the study began, a simple randomization is done with the Excel software (Version 2010, Microsoft). The randomly assigned three type of IOL was implanted during cataract surgery.

The same experienced surgeon (CKJ) performed all cataract surgeries using a standard procedure. Except intraocular lens, the postoperative protocol was same in all groups. At week one, two and six months postoperatively, the area of the anterior capsule opening in these patients was measured using digital retro-illumination images after dilating the pupil, followed by evaluation using the POCOman software.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Anterior Capsule Opening Size is measured by analyzing the image of digital retro-illumination using POCOman software at 1 week, 2, and 6 months postoperatively.

Secondary outcome measures

Posterior Capsule Opacification is measured also by analyzing the image of digital retro-illumination using POCOman software at 1 week, 2, and 6 months postoperatively.

Overall trial start date

01/08/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 55 years and under 75
2. Presence of age-related cataract
3. Axial length within the normal range (22–25.5 mm)
4. Dilated pupil larger than 8.0 mm in diameter

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Ocular disease
2. Intraocular surgery
3. Laser treatment
4. Glaucoma
5. Severe retinal pathology

Recruitment start date

02/08/2016

Recruitment end date

28/02/2018

Locations

Countries of recruitment

Korea, South

Trial participating centre

Seoul St. Mary’s Hospital
Department of Ophthalmology College of Medicine The Catholic University of Korea, Seoul, Republic of Korea 222, Banpo-daero, Seocho-gu Republic of Korea
Seoul
06591
Korea, South

Sponsor information

Organisation

Ethics Committee of the Seoul St. Mary’s Hospital

Sponsor details

222
Banpo-daero
Seocho-gu
Republic of Korea
Seoul
06591
Korea
South
+82 2258 8200
seoul_irb@catholic.ac.kr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plans to publish in BMC ophthalmology.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mihyun Choi, MD at MNyoung23@gmail.com

Intention to publish date

01/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes