Comparison of macular thickness and inflammatory cytokine levels after microincision versus small incision coaxial cataract surgery
| ISRCTN | ISRCTN69290731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69290731 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/12/2013
- Registration date
- 03/01/2014
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Our goal is to compare the effects of cataract surgery performed using two different sizes of incision (microincision versus small incision).
Who can participate?
Participants who are due to undergo cataract surgery and whose eyes nuclear density ranges from Grade 3 to 4 can take part.
What does the study involve?
Participants will be randomly allocated to one of two groups. One group undergoes cataract surgery with a microincision and the other group undergoes the surgery using a small incision. Clinical measurements are taken before the surgery and one week, one month and two months after the surgery. Participants will be invited to give blood for further blood tests before the surgery and one week after the surgery is completed.
What are the possible benefits and risks of participating?
There is no risk to participants.
Where is the study run from?
The study is run from Bucheon St Mary's Hospital, South Korea.
When is study starting and how long is it expected to run for?
Recruitment started in early 2010. Participants were enrolled in the study for a period of six months; between May 2010 and December 2010.
Who is funding the study?
This study is funded by the National Research Foundation of Korea (NRF).
Who is the main contact?
Professor Eun Chul Kim
eunchol@hanmail.net
Contact information
Scientific
Bucheon St Mary's Hospital
# 2 Sosa-Dong
Wonmi-Ku
Bucheon
420-717
Korea, South
Study information
| Study design | Randomized comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 | Comparison of macular thickness and inflammatory cytokine levels after microincision versus small incision coaxial cataract surgery: a randomized, comparative clinical trial |
| Study objectives | The pathophysiology of cystoid macular edema (CME) is likely to be multifactorial, but postoperative inflammation and breakdown of the bloodaqueous barrier seem to be important risk factors of onset and subsistence of CME. In this study we compared the macular thickness changes and levels of inflammatory cytokines after microincision versus small incision coaxial cataract surgery. |
| Ethics approval(s) | Institutional Review Board at the Bucheon St Mary's Hospital, 07/12/2013, HC13RISI0136 |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | This prospective randomized study included 84 eyes which were randomly allocated to one of the following two treatments: 1. Phacoemulsification with microincision coaxial cataract surgery (2.2 mm incision) 2. Phacoemulsification with small incision |
| Intervention type | Other |
| Primary outcome measure | 1. Intraoperative measurements included: 1.1. Ultrasound time (UST) 1.2. Mean cumulative dissipated ultrasound energy (CDE) 1.3. Total balanced salt solution (BSS) use 2. Clinical measurements included preoperative, 1-week postoperative, 1-month postoperative and 2-month postoperative: 2.1. Best corrected visual acuity (BCVA) 2.2. Central corneal thickness (CCT) 2.3. Endothelial cell count (ECC) |
| Secondary outcome measures | Enzyme-linked immunosorbent assay (ELISA) and reverse transcription polymerase chain reaction (RT-PCR) were performed for IL-1alpha, IL-6, VEGF and PGE2 preoperatively and at 1 week postoperatively |
| Overall study start date | 01/05/2010 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 84 patients |
| Total final enrolment | 84 |
| Key inclusion criteria | Eyes with nuclear density from Grade 3 to 4 |
| Key exclusion criteria | 1. Corneal pathology 2. Pseudoexfoliation 3. History of ocular trauma 4. Intraoperative complications such as posterior lens capsule rupture, lens dislocation and ocular inflammation |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
420-717
Korea, South
Sponsor information
Government
201 Gajung-Ro
Yousung- Gu
Daejun
404-829
Korea, South
| Website | http://www.nrf.re.kr |
|---|---|
"ROR" |
https://ror.org/013aysd81 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference and total final enrolment added.
