This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.Over 100 patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject will accept 5 times assessments:the day before surgery, surgery day , the day after surgery,a week after surgery and a month after surgery.Each time a subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire et.al.The purpose is to evaluate the effect of Cornea Protect to maintain intraoperative clarity and to prevent the postoperative xerophthalmia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
100
We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
Balanced Salt Solution including normal saline and glucose
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGchange from baseline dry eye condition at 1 month
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Time frame: an expected average of a month after the surgery
Intraoperative corneal clarity
record the times of using HPMC or BSS during the surgery to maintain the intraoperative corneal clarity and how long it lasts.
Time frame: during the surgery
change from baseline corneal damage at 1 month
Corneal damage evaluated by fluorescence staining of cornea
Time frame: an expected average of a month after the surgery
Inflammation
Inflammation evaluated by Anterior chamber scintillation
Time frame: an expected average of a month after the surgery
change from baseline dry eye condition at 1 week
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Time frame: an expected average of a week after the surgery
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