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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 â… 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 â… 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPMC group | Experimental | Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery. |
|
| BSS group | Placebo Comparator | Patients use balanced salt solution (BSS) during the cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxypropyl ethylcellulose (HPMC) 2% gel | Device | We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery. |
| 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 â… 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 |
| 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 â… test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wangshu Yu, MD | Contact | 0086-15088733997 | yuwangshu@zju.edu.cn | |
| Xiuming Jin, PhD | Contact | 008613989455778 | lzyjxm@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ke Yao, PhD | Eye Center of the Second Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center of the Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21782381 | Result | Chen YA, Hirnschall N, Findl O. Comparison of corneal wetting properties of viscous eye lubricant and balanced salt solution to maintain optical clarity during cataract surgery. J Cataract Refract Surg. 2011 Oct;37(10):1806-8. doi: 10.1016/j.jcrs.2011.07.001. Epub 2011 Jul 22. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D014985 | Xerophthalmia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D003229 | Conjunctival Diseases |
| D015352 | Dry Eye Syndromes |
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|
| BSS | Device | Balanced Salt Solution including normal saline and glucose |
|
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| an expected average of a week after the surgery |
| D007766 |
| Lacrimal Apparatus Diseases |