Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery

April 2, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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, 310009
        • Second Affiliated Hospital, Zhejiang University School of Medicine

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age-related cataract
  2. dry eye disease

Exclusion Criteria:

  1. a history of surgery and other ocular diseases
  2. contact lens use
  3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Procedure: phacoemulsification
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Experimental: BCL group
Procedure: phacoemulsification
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Device: bandage contact lenses
wear bandage contact lensesfor a week after cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Ocular Surface Disease Index at 1 week
Time Frame: 0 day, 1 week postoperative
Ocular Surface Disease Index
0 day, 1 week postoperative
Change from Baseline Ocular Surface Disease Index at 1 month
Time Frame: 0 day, 1 month postoperative
Ocular Surface Disease Index
0 day, 1 month postoperative
Change from Baseline meibography score at 1 week
Time Frame: 0 day, 1 week postoperative
meibography score
0 day, 1 week postoperative
Change from Baseline meibography score at 1 month
Time Frame: 0 day, 1 month postoperative
meibography score
0 day, 1 month postoperative
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
Time Frame: 0 day, 1 month postoperative
non-invasive keratograph tear meniscus height
0 day, 1 month postoperative
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
Time Frame: 0 day, 1 week postoperative
non-invasive keratograph tear meniscus height
0 day, 1 week postoperative
Change from Baseline noninvasive tear breakup time at 1 week
Time Frame: 0 day, 1 week postoperative
noninvasive tear breakup time
0 day, 1 week postoperative
Change from Baseline noninvasive tear breakup time at 1 month
Time Frame: 0 day, 1 month postoperative
noninvasive tear breakup time
0 day, 1 month postoperative
Change from Baseline Schirmer I test at 1 week
Time Frame: 0 day, 1 week postoperative
Schirmer I test
0 day, 1 week postoperative
Change from Baseline Schirmer I test at 1 month
Time Frame: 0 day, 1 month postoperative
Schirmer I test
0 day, 1 month postoperative
slit-lamp examination
Time Frame: 0 day
slit-lamp examination
0 day
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
Time Frame: 0 day and 1 month postoperative
cytokine levels
0 day and 1 month postoperative

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

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 (Actual)

September 1, 2018

Primary Completion (Actual)

December 6, 2020

Study Completion (Actual)

December 6, 2020

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xuwen2018-082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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