To assess the changes of ocular surface and tear film in patients with meibomian glands dysfunction (MGD), who are given intense pulse light therapy, and to compare it with controls.
Design
This Clinical trial consists of parallel groups (Fifty patients with MGD in control and intervention groups), which will be simply randomized for the intervention and will be double blinded.
Settings and conduct
Noorafarin eye clinic, Mashhad
Participants/Inclusion and exclusion criteria
One hundred patients with MGD will be recruited if they are eligible for the study:
Inclusion criteria:
Having ethical consent for participation in the study, having history of MGD treatment for at least two months.
Exclusion criteria:
Having any systemic or ocular disease or history of ophthalmic surgeries.
contact lens users,
Taking medications with photo sensitivity side effect, like steroids and retinoids
Having tattoos in palpebral and peri orbital region.
Lactation and pregnancy
Intervention groups
Fifty patients who are given intense pulse light therapy for meibomian gland dysfunctions.
Fifty MGD patients in control group are not given IPL therapy, but they will underwent the conventional treatment for MGD.
Main outcome variables
Tear meniscus height, tear break up time, OSDI score, meibography upper and lower lid, meibomian gland expressibility, SM tube meniscometry, tear osmolarity, bulbar and conjunctival redness, conjunctival chalasis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190507043503N1
Registration date:2019-07-13, 1398/04/22
Registration timing:registered_while_recruiting
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Samira Hassanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 3848
Email address
hasanzadehs951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the effect of intense pulse light therapy in Iranian patients with meibomian gland dysfunction.
Public title
To assess tear film changes after intense pulse light therapy in Iranian patients with meibomian gland dysfunction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of meibomian gland dysfunction according to international diagnostic criteria
Patients who have ethical consent for participating in the study
Patients who have the history of at least 2 months taking current medications for meibomian gland dysfunction.
Exclusion criteria:
Having any ocular or systemic disease
Having any history of ophthalmic surgeries
Taking medications with photo sensitivity side effects
Contact lens wearers
Having nevus or tattoos in palpebral and peri orbital region
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using pocket. For each patient, we will put the label of intervention and control groups in a pocket and the practitioner will randomly takes out a label from the pocket. The patient will be allocated to the selected group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in both intervention and control groups will be given the current medications for meibomian glands dysfunction and they will not be aware of their allocation. The investigator who will follow the patients and perform the tests, will be also unaware about the groups allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
#155, Mahdi 2 ave., Mahdi st, Ferdowsi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197984767
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.MUMS.REC.1398.081
Health conditions studied
1
Description of health condition studied
Meibomian gland dysfunction
ICD-10 code
H04.1
ICD-10 code description
Evaporative dry eye- dry eye syndrome
Primary outcomes
1
Description
OSDI score: this ocular surface index questionnaire consists of 12 question and assesses the severity of dry eye.
Timepoint
Baseline, day 14, day 45, day 75
Method of measurement
sum of score of questionnaire which has been filled by the patients
2
Description
TBUT : tear break up time
Timepoint
Baseline, day 14, day 45, day 75
Method of measurement
keratograph, slit lamp
3
Description
osmolarity: tear film density
Timepoint
baseline, day 75
Method of measurement
tear lab device
Secondary outcomes
1
Description
meibomian gland drop out which is graded from 0 to 3.
Timepoint
baseline, day 14, day 45, day 75
Method of measurement
keratograph device
2
Description
PSQI: Pittsburgh sleep quality index
Timepoint
BASELINE, DAY 75
Method of measurement
Sum of score of questionnaire which has been filed by the patients
Intervention groups
1
Description
Intervention group: 50 patients with meibomian gland dysfunction will undergo 3 sessions of intense pulse light therapy. Meanwhile routine dry eye therapy consisting using artificial tears, massage and warm compress will be continued.
Category
Treatment - Devices
2
Description
Control group: 50 patients with meibomian gland dysfunction who will undergo routine dry eye therapy consisting using artificial tears, massage and warm compress and will follow up similar to intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noorafarin eye clinic
Full name of responsible person
Samira Hassanzadeh
Street address
No. 231, Mahdi intersection, Ferdowsi blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197985768
Phone
+98 51 3766 6150
Email
info@noorafarineyeclinic.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research Deputy of Mashhad University of Medical Sciences.