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IRCT20190507043503N1 IRCT 2019-07-13 Mashhad University of Medical Sciences To assess tear film changes after intense pulse light therapy in Iranian patients with meibomian gland dysfunction. To assess the effect of intense pulse light therapy in Iranian patients with meibomian gland dysfunction. 2019-05-22 anticipated 100 Complete https://irct.ir/trial/39334 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Meibomian gland dysfunction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data will be available after data analysis. When: Starting 6 months after publication To whom: For academic staff Conditions: Data will be available on researchers' request. Where to obtain: Sending request via research gate website How to obtain: Access will be possible on request . Comments:
public Samira Hassanzadeh
#155, Mahdi 2 ave., Mahdi st, Ferdowsi Blvd.
Mashhad Iran (Islamic Republic of) 9197984767 +98 915 158 1572 samip2005@yahoo.com Mashhad University of Medical Sciences scientific Samira Hassanzadeh
No.155, Mahdi 2 st., Mahdi Ave., Ferdowsi Blvd.
Mashhad Iran (Islamic Republic of) 9197984767 +98 51 3768 3848 hasanzadehs951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both 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 H04.1 Evaporative dry eye- dry eye syndrome Treatment - Devices Treatment - Other 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. 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. 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. TBUT : tear break up time. Timepoint: Baseline, day 14, day 45, day 75. Method of measurement: keratograph, slit lamp. Osmolarity: tear film density. Timepoint: baseline, day 75. Method of measurement: tear lab device. Meibomian gland drop out which is graded from 0 to 3. Timepoint: baseline, day 14, day 45, day 75. Method of measurement: keratograph device. PSQI: Pittsburgh sleep quality index. Timepoint: BASELINE, DAY 75. Method of measurement: Sum of score of questionnaire which has been filed by the patients. Mashhad University of Medical Sciences Approved 2019-06-18 Ethics committee of Mashhad University of Medical Sciences #155, Mahdi 2 ave., Mahdi st, Ferdowsi Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)