Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of macular thickness and inflammatory cytokine levels after microincision versus small incision coaxial cataract surgery: a randomized, comparative clinical trial
Acronym
Study hypothesis
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
Institutional Review Board at the Bucheon St Mary's Hospital, 07/12/2013, HC13RISI0136
Study design
Randomized comparative clinical 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 the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/05/2010
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Eyes with nuclear density from Grade 3 to 4
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
84 patients
Total final enrolment
84
Participant 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
Recruitment start date
01/05/2010
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Korea, South
Trial participating centre
Bucheon St Mary's Hospital
Bucheon
420-717
Korea, South
Sponsor information
Organisation
The National Research Foundation of Korea (NRF) (South Korea)
Sponsor details
201 Gajung-Ro
Yousung- Gu
Daejun
404-829
Korea
South
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The National Research Foundation of Korea (NRF) (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://pubmed.ncbi.nlm.nih.gov/25828946/ (added 17/12/2020)