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Corneal Protect Used During Cataract Surgery (CPUDCS)

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydroxypropyl ethylcellulose (HPMC) 2% gel
BSS
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cataract focused on measuring cataract surgery, cornea protect, xerophthalmia, Corneal clarity

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eye Center of the Second Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPMC group

BSS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
change from baseline corneal damage at 1 month
Corneal damage evaluated by fluorescence staining of cornea

Secondary Outcome Measures

Inflammation
Inflammation evaluated by Anterior chamber scintillation
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.

Full Information

First Posted
February 5, 2015
Last Updated
November 19, 2015
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02363530
Brief Title
Corneal Protect Used During Cataract Surgery
Acronym
CPUDCS
Official Title
Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract surgery, cornea protect, xerophthalmia, Corneal clarity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPMC group
Arm Type
Experimental
Arm Description
Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery.
Arm Title
BSS group
Arm Type
Placebo Comparator
Arm Description
Patients use balanced salt solution (BSS) during the cataract surgery.
Intervention Type
Device
Intervention Name(s)
Hydroxypropyl ethylcellulose (HPMC) 2% gel
Other Intervention Name(s)
Cornea Protect
Intervention Description
We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
Intervention Type
Device
Intervention Name(s)
BSS
Other Intervention Name(s)
Balanced Salt Solution
Intervention Description
Balanced Salt Solution including normal saline and glucose
Primary Outcome Measure Information:
Title
change from baseline dry eye condition at 1 month
Description
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
Title
Intraoperative corneal clarity
Description
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
Title
change from baseline corneal damage at 1 month
Description
Corneal damage evaluated by fluorescence staining of cornea
Time Frame
an expected average of a month after the surgery
Secondary Outcome Measure Information:
Title
Inflammation
Description
Inflammation evaluated by Anterior chamber scintillation
Time Frame
an expected average of a month after the surgery
Title
change from baseline dry eye condition at 1 week
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wangshu Yu, MD
Phone
0086-15088733997
Email
yuwangshu@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuming Jin, PhD
Phone
008613989455778
Email
lzyjxm@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke Yao, PhD
Organizational Affiliation
Eye Center of the Second Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Center of the Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wangshu Yu, MD
Phone
008615088733997
Email
yuwangshu@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiuming Jin, PhD
Phone
008613989455778
Email
lzyjxm@zju.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
21782381
Citation
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.
Results Reference
result

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Corneal Protect Used During Cataract Surgery

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