Condition category
Eye Diseases
Date applied
11/12/2013
Date assigned
03/01/2014
Last edited
19/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Eun Chul Kim

ORCID ID

Contact details

Bucheon St Mary's Hospital
# 2 Sosa-Dong
Wonmi-Ku
Bucheon
420-717
Korea
South

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 blood–aqueous 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 measures

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

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

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

http://www.nrf.re.kr

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes