Effect of number and position of haptic on anterior capsule contraction
| ISRCTN | ISRCTN76566080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76566080 |
| Secondary identifying numbers | KC18RESI0081 |
- Submission date
- 06/02/2018
- Registration date
- 14/02/2018
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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
Contact information
Scientific
Seoul St. Mary’s Hospital
222, Banpo-daero, Seocho-gu
Republic of Korea
Seoul
06591
Korea, South
 ORCID ID |
0000-0003-0535-4118 |
|---|---|
| Phone | +82 02 2258 6329 |
| ckjoo@catholic.ac.kr |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of number and position of intraocular lens haptics on anterior capsule contraction: A randomised, prospective trial |
| 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(s) | Ethics Committee of the Seoul St. Mary’s Hospital Korea, 05/02/2016, ref: KC18RESI0081 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/08/2016 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| 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 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
Study participating centre
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
Hospital/treatment centre
222, Banpo-daero, Seocho-gu
Republic of Korea
Seoul
06591
Korea, South
| Phone | +82 2258 8200 |
|---|---|
| seoul_irb@catholic.ac.kr | |
"ROR" |
https://ror.org/056cn0e37 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans to publish in BMC ophthalmology. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/03/2018 | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
