NCT02363530

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

February 5, 2015

Last Update Submit

November 19, 2015

Conditions

Cataract

Keywords

cataract surgerycornea protectxerophthalmiaCorneal clarity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

Secondary Outcomes (2)

  • Inflammation

    an expected average of a month after the surgery

  • change from baseline dry eye condition at 1 week

    an expected average of a week after the surgery

Study Arms (2)

HPMC group

EXPERIMENTAL

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

Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel

BSS group

PLACEBO COMPARATOR

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

Device: BSS

Interventions

Hydroxypropyl ethylcellulose (HPMC) 2% gelDEVICE

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

Also known as: Cornea Protect
HPMC group
BSSDEVICE

Balanced Salt Solution including normal saline and glucose

Also known as: Balanced Salt Solution
BSS group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related 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.2011.07.001. Epub 2011 Jul 22.

    PMID: 21782381RESULT

MeSH Terms

Conditions

CataractXerophthalmia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesConjunctival DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Study Officials

  • Ke Yao, PhD

    Eye Center of the Second Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangshu Yu, MD

CONTACT

0086-15088733997yuwangshu@zju.edu.cn

Xiuming Jin, PhD

CONTACT

008613989455778lzyjxm@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 16, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)