Corneal Protect Used During Cataract Surgery

Cataract Clinical Trial

— CPUDCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363530
• Other study ID #: Corneal Protect
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2015
• Last updated: November 19, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wangshu Yu, MD
• Phone: 0086-15088733997
• Email: yuwangshu[@]zju.edu.cn
• Is FDA regulated: No
• Health authority: Human Research Ethics Committee of The Second Affiliated Hospital of Zhejiang University:China
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Hydroxypropyl ethylcellulose (HPMC) 2% gel
We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
• BSS
Balanced Salt Solution including normal saline and glucose

Locations

Country	Name	City	State
China	Eye Center of the Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.	an expected average of a month after the surgery	No
Primary	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	No
Primary	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	No
Secondary	Inflammation	Inflammation evaluated by Anterior chamber scintillation	an expected average of a month after the surgery	No
Secondary	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 ? test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.	an expected average of a week after the surgery	No