Corneal Protect Used During Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.

Conditions
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Cataract

Intervention / Treatment
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* Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel
* Device: BSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with cataracts; aged 40 to 85 years old, gender not limited; plans to accept PHACO and intraocular lens(IOL)implantation surgery the lens nucleus hardness level is less than 3 ; signed informed consent. Exclusion Criteria: allergic to any of the drugs or device in this study ； existence of other infectious diseases or allergic conjunctivitis. the eye had been chemical burned or thermal burned diagnosed as Stevens Johnson syndrome or eye-pemphigoid. diagnosed with glaucoma or high intraocular pressure; existence of eyelid and lacrimal duct disease; received any eye surgery in 3 months; wearing corneal contact lens; history suggests there are serious heart, lung, liver or renal function disorder; pregnancy or lactation women; Other conditions considered not appropriate by the investigators.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPMC group<br>Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery. | Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel<br>* We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.<br>* Other names: Cornea Protect;|
| Placebo Comparator: BSS group<br>Patients use balanced salt solution (BSS) during the cataract surgery. | Device: BSS<br>* Balanced Salt Solution including normal saline and glucose<br>* Other names: Balanced Salt Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change 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. | 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. | during the surgery | 
| change from baseline corneal damage at 1 month | Corneal damage evaluated by fluorescence staining of cornea | an expected average of a month after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Inflammation evaluated by Anterior chamber scintillation | 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. | an expected average of a week after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, cornea protect, xerophthalmia, Corneal clarity