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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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1 April 2019 |
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Main ID: |
ChiCTR1900021273 |
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Date of registration:
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2019-02-09 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinic Results of Intraductal Meibomian Gland Probing Combined Intense Pulsed Light in Treating Patients With Refractory Obstructive Meibomian Gland Dysfunction: a randomized controlled trial
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Scientific title:
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Clinic Results of Intraductal Meibomian Gland Probing Combined Intense Pulsed Light in Treating Patients With Refractory Obstructive Meibomian Gland Dysfunction: a randomized controlled trial |
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Date of first enrolment:
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2018-07-01 |
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Target sample size:
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Group 1:30;Group 2:30;Group 3:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=34935 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Qin Qiyu
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Address:
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88 Jiefang Road, Shangcheng District, Hangzhou, China
310009
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Telephone:
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+86 18757163724 |
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Email:
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18344980414@163.com |
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Affiliation:
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Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University |
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Name:
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Jin Xiuming
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Address:
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88 Jiefang Road, Shangcheng District, Hangzhou, China
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Telephone:
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+86 571 87783897 |
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Email:
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lzyjxm@zju.edu.cn |
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Affiliation:
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Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged over 18 years;
2. Fitzpatrick Skin Type 1-4;
3. Standard patient evaluation of eye dryness (SPEED) questionnaire=6;
4. Meibum grade=24 and more than half of the 15 evaluated meibomian gland orifices in each eyelid were obstructed and had no lipid secretion with extrusion;
5. Breakup time of tear film (TBUT) =5s;
6. Schirmer test >5s;
7. Meibo-Scan (OCULUS) showed the atrophy area of meibomian gland in both upper and lower eyelids less than 1/3 of the total area;
8. Did not have symptom relief with conservative treatment (eyelid warming, massage and artificial tears) for at least 1 year before study treatment;
9. Sign informed consent.
Exclusion criteria: Patients with history of corneal contact lens, mite blepharitis, acute eye inflammation or infection and apparent eyelid margin scar as well as patients using lacrimal plug or receiving LASIK were excluded from our study.
Age minimum:
18
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Refractory Obstructive Meibomian Gland Dysfunction
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Intervention(s)
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Group 1:Intraductal Meibomian Gland Probing;Group 2:Intense Pulsed Light;Group 3:intraductal meibomian gland probing (MGP) combined intense pulsed light;
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Primary Outcome(s)
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Standard Patient Evaluation of Eye Dryness score;Tear break-up time (TBUT);Corneal fluorescein staining (CFS);
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Secondary Outcome(s)
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Lid margin finding results;Meibum grade;
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Source(s) of Monetary Support
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National Natural Science Foundation of China: [grant numbers: 81870624]; Major Science and Technology Projects of Zhejiang Province [grant numbers: 2017C03046].
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Ethics review
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Status: Approved
Approval date: 12/06/2018
Contact:
Chen Haile
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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