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.
Cyclosporine A (CsA) eye drops are a new treatment for MGD and dry eye syndrome after cataract surgery. The usual treatment is with Carboxymethyl cellulose (CMC) eye drops.
Who can participate?
Adult cataract patients with normal lid position and closure and not suffering from any ocular diseases.
What does the study involve?
Participants will be randomly allocated to receive 0.05% CsA or 0.5% Carboxymethyl cellulose (CMC) over three months following cataract surgery. Subjective and objective assessments are performed in each preoperative and postoperative visit.
What are the possible benefits and risks of participating?
When participating in the study, there might be no risks or benefits for patients. This is a controlled study comparing the group with and without the use of specific eye drops that are commercially available and have clinical safety. There is no direct benefit when the patient participates in the study.
Where is the study run from?
Department of Ophthalmology, Pusan National University School of Medicine, Yangsan (South Korea)
When is the study starting and how long is it expected to run for?
April 2019 to November 2019
Who is funding the study?
Pusan National University Yangsan Hospital (South Korea)
Who is the main contact?
Dr Min Seung Min Seung, kangminseung91@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Min Seung Kang
ORCID ID
https://orcid.org/0000-0001-5026-4117
Contact details
Pusan National University School of Medicine
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 55-360-1447
kangminseung91@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Efficacy of 0.05% Cyclosporine A on the lipid layer and meibomian gland after cataract surgery: a randomized, double-masked study
Acronym
Study hypothesis
0.05% cyclospoine A might improve MGD dysfunction and dry eye syndrome by comparison to 0.5% carboxymethyl cellulose after cataract surgery.
Ethics approval
Approved 04/04/2019, Pusan National University Yangsan Hospital Institutional Review Board (#20 Geumo-ro, Mulgeum-eup, Yangsan 50612, South Korea; +82-55-360-3854; 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 below to request a patient 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 0.05% CsA ophthalmic emulsion (Restasis®, Allergan Inc., Irvine, CA) twice daily over three months following cataract surgery. The second group receive standard postoperative treatment with 0.5% carboxymethyl cellulose (CMC) (Refresh plus®, Allergan Inc., Irvine, CA).
Intervention type
Drug
Phase
Not Applicable
Drug names
0.05% CsA ophthalmic emulsion (Restasis®, Allergan Inc., Irvine, CA); 0.5% carboxymethyl cellulose (CMC) (Refresh plus®, Allergan Inc., Irvine, CA)
Primary outcome measure
At baseline and three months.
1. Ocular surface status parameters:
1.1. Lipid layer thickness (LLT) using an interferometer
1.2. Schirmer’s type I test
1.3. Tear breakup time (TBUT)
2. Ocular Surface Disease Index (OSDI) questionnaire to evaluate the patients’ symptoms
3. Meiboscores with the LipiView® interferometer to calculate the degree of meibomian gland dysfunction
Secondary outcome measures
none
Overall trial start date
01/01/2018
Overall trial end date
30/11/2019
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
50 patients
Total final enrolment
50
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
04/04/2019
Recruitment end date
31/05/2019
Locations
Countries of recruitment
Korea, South
Trial participating centre
Pusan National University School of Medicine
Department of Ophthalmology
20-Geumo-ro
Mulgeum-eup
Yang San
50612
Korea, South
Sponsor information
Organisation
Pusan National University Yangsan Hospital
Sponsor details
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 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 current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
20/04/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN10173448_PROTOCOL.pdf uploaded 15/05/2020