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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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18 April 2017 |
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Main ID: |
ChiCTR-INR-16010074 |
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Date of registration:
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2016-12-02 |
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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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The effect of eyepoint for early dryeye and patient satisfaction after small incision lenticule extraction
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Scientific title:
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The effect of eyepoint for early dryeye and patient satisfaction after small incision lenticule extraction |
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Date of first enrolment:
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2016-09-21 |
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Target sample size:
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experimental group:30;control group: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=15951 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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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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Xiaopeng Ma
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Address:
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650 South Wanping Road, Xuhui District, Shanghai, China
200030
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Telephone:
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+86 13917140446 |
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Email:
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pengpengma@163.com |
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Affiliation:
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Shanghai Research Institute of Acupuncture and Meridian |
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Name:
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Xiaofei Huang
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Address:
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650 South Wanping Road, Xuhui District, Shanghai, China
200030
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Telephone:
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+86 18801967576 |
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Email:
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869268156@qq.com |
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Affiliation:
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Shanghai University of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Patient who suffer dry eye after SMILE;
(2) Aged 18 to 40 years old;
(3) Preoperative concave-sphere -3.0 to -10.0DS.Preoperative concave-cylinder:0 to 5.0DC;
(4) Patient who didn't suffer dry eye before operation;
(5) Patient with good compliance who volunteers to join the subject and signs informed consent.
Exclusion criteria: (1) Patient who use any ocular surface medicine before examination on the day;
(2) Patient who suffered external eye disease or took operation of external eye in 6 months;
(3) Patient who took permanent or temporary smart plug in half year before this operation;
(4) Patient who is suffering else eye disease;
(5) Patient who use other oral medicine or external medicine which treat eye disease at the same time;
(6) Patient who is in gestation period or lactation;
(7) Patient who has cardiovascular, cerebrovascular, hepatic, renal, hematopoietic systematic diseases or other systematic disease and mental disease.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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early dry eye after SMILE
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Intervention(s)
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experimental group:eyepoint with artificial tears;control group:artificial tears;
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Primary Outcome(s)
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tear film break-up time;Schimer I test;corneal sensitivity;tear meniscus height;
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Source(s) of Monetary Support
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Shanghai Research Institute of Acupuncture and Meridian
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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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