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Corneal Protect Used During Cataract Surgery

NCT ID: NCT02363530

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HPMC group

Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery.

Group Type EXPERIMENTAL

Hydroxypropyl ethylcellulose (HPMC) 2% gel

Intervention Type DEVICE

We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.

BSS group

Patients use balanced salt solution (BSS) during the cataract surgery.

Group Type PLACEBO_COMPARATOR

BSS

Intervention Type DEVICE

Balanced Salt Solution including normal saline and glucose

Interventions

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Hydroxypropyl ethylcellulose (HPMC) 2% gel

We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.

Intervention Type DEVICE

BSS

Balanced Salt Solution including normal saline and glucose

Intervention Type DEVICE

Other Intervention Names

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Cornea Protect Balanced Salt Solution

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Wangshu Yu

Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke Yao, PhD

Role: PRINCIPAL_INVESTIGATOR

Eye Center of the Second Affiliated Hospital of Zhejiang University

Locations

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Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wangshu Yu, MD

Role: CONTACT

[email protected]
0086-15088733997

Xiuming Jin, PhD

Role: CONTACT

[email protected]
008613989455778

Facility Contacts

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Wangshu Yu, MD

Role: primary

[email protected]
008615088733997

Xiuming Jin, PhD

Role: backup

[email protected]
008613989455778

References

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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.

Reference Type RESULT
PMID: 21782381 (View on PubMed)

Other Identifiers

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Corneal Protect

Identifier Type: -

Identifier Source: org_study_id