Condition category
Eye Diseases
Date applied
28/03/2020
Date assigned
06/04/2020
Last edited
15/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.pnuyh.or.kr/pnuh/main/main.do?rbsIdx=1

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

Editorial Notes

15/05/2020: Uploaded protocol (not peer reviewed) as an additional file. 06/04/2020: Trial’s existence confirmed by Pusan National University Yangsan Hospital Institutional Review Board.