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)
Effect of number and position of intraocular lens haptics on anterior capsule contraction: A randomised, prospective trial
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 Committee of the Seoul St. Mary’s Hospital Korea, 05/02/2016, ref: KC18RESI0081
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
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Patient who have age related cataract in Seoul St.Mary's hospital.
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.
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
Overall trial end date
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
Target number of participants
Participant exclusion criteria
1. Ocular disease
2. Intraocular surgery
3. Laser treatment
5. Severe retinal pathology
Recruitment start date
Recruitment end date
Countries of recruitment
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
Ethics Committee of the Seoul St. Mary’s Hospital
Republic of Korea
+82 2258 8200
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
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
Participant level data
Available on request
Results - basic reporting