Plain English Summary
Background and study aims
Cataracts are when the lens of your eye, a small transparent disc, develops cloudy patches. Cataract surgery involves replacing the cloudy lens inside the eye with an artificial one. The Meibomian glands along the rims of the eyelid produce meibum, an oily substance that prevents evaporation of the eye's tear film. Meibomian gland dysfunction (MGD) often occurs after cataract surgery. Diquafosol sodium eye solution is a new treatment for MGD and dry eye syndrome after cataract surgery. One of the usual treatments for post-cataract surgery is sodium hyaluronate eye drops. The aim of this study is to find out whether diquafosol sodium eye drops improve MGD dysfunction and dry eye syndrome after cataract surgery in comparison with sodium hyaluronate eye drops.
Who can participate?
Adult cataract patients with normal lid position and closure and not suffering from any eye diseases
What does the study involve?
Participants will be randomly allocated to use diquafosol sodium or sodium hyaluronate eye drops for 4 months following cataract surgery. Eye assessments are performed at each visit before and after surgery.
What are the possible benefits and risks of participating?
There may be no risks or benefits for the participants. The eye drops are commercially available and have proven clinical safety.
Where is the study run from?
Pusan National University School of Medicine (South Korea)
When is the study starting and how long is it expected to run for?
January 2019 to December 2020
Who is funding the study?
Pusan National University Yangsan Hospital (South Korea)
Who is the main contact?
Dr Sangyoon Kim
ksy9404@naver.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sangyoon Kim
ORCID ID
Contact details
Pusan National University School of Medicine
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 1447
ksy9404@naver.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Efficacy of 3% diquafosol sodium on the lipid layer and meibomian gland after cataract surgery: a randomized, double-masked study
Acronym
Study hypothesis
3% diquafosol sodium might improve meibomian gland (MGD) dysfunction and dry eye syndrome in comparison with 0.1% sodium hyaluronate after cataract surgery.
Ethics approval
Approved 20/01/2020, Pusan National University Yangsan Hospital Institutional Review Board (#20 Geumo-ro, Mulgeum-eup, Yangsan 50612, South Korea; +82 (0)55 360 3854; pnuyhirb@gmail.com), ref: 05-2019-049
Study design
Prospective randomized double-masked comparative clinical trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Dry eye syndrome, meibomian gland dysfunction
Intervention
Eligible patients are randomized using the random number method into two treatment groups. The first group will use 3% diquafosol sodium ophthalmic solution (Diquas-s®, Mitsubishi Tanabe Pharma Inc., Osaka, Japan) six times daily over 4 months following cataract surgery. The second group receive standard postoperative treatment with 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea).
Intervention type
Drug
Phase
Not Applicable
Drug names
3% diquas sodium ophthalmic solution(Diquas-s®, Mitsubishi Tanabe Pharma Inc., Osaka, Japan); 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea)
Primary outcome measure
Measured at baseline and 4 months:
1. Ocular surface status parameters:
1.1. Lipid layer thickness (LLT) measured using an interferometer
1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc.
1.3. Tear breakup time (TBUT) measured by an ophthalmologist
2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire
3. Meibomian gland dysfunction assessed using Meiboscores with the LipiView® interferometer
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/01/2019
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult cataract patients with normal lid position and closure and not suffering from any ocular diseases
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Total final enrolment
60
Participant exclusion criteria
1. Patients who had used topical anti-inflammatory, antibiotic, or other medication during the previous 90 days before surgery
2. Eyes with a history of trauma, ocular surgery, laser or systemic treatment known to affect tear secretion, autoimmune disease, current use of contact lenses, and/or history of slit-lamp evidence of eye surface disorders
Recruitment start date
11/04/2019
Recruitment end date
18/02/2020
Locations
Countries of recruitment
Korea, South
Trial participating centre
Pusan National University School of Medicine
Department of Ophthalmology
20-Geumo-ro Mulgeum-eup
Yangsan
50612
Korea, South
Sponsor information
Organisation
Pusan National University Yangsan Hospital
Sponsor details
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 1447
jiel75@hanmail.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Pusan National University Yangsan Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
20/01/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list