Corneal Protect Used During Cataract Surgery (CPUDCS)

November 19, 2015 updated by: Wangshu Yu, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • Eye Center of the Second Affiliated Hospital of Zhejiang University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPMC group
Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery.
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.
Other Names:
  • Cornea Protect
Placebo Comparator: BSS group
Patients use balanced salt solution (BSS) during the cataract surgery.
Device: BSS
Balanced Salt Solution including normal saline and glucose
Other Names:
  • Balanced Salt Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline dry eye condition at 1 month
Time Frame: an expected average of a month after the surgery
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
Time Frame: during the surgery
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
Time Frame: an expected average of a month after the surgery
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
Time Frame: an expected average of a month after the surgery
Inflammation evaluated by Anterior chamber scintillation
an expected average of a month after the surgery
change from baseline dry eye condition at 1 week
Time Frame: an expected average of a week after the surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Ke Yao, PhD, Eye Center of the Second Affiliated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Corneal Protect

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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