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

Primary Purpose

Cataract, Dry Eye

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bandage contact lenses
phacoemulsification
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Affiliated Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCL group

control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
April 2, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04100031
Brief Title
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
Official Title
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCL group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
bandage contact lenses
Intervention Description
wear bandage contact lensesfor a week after cataract surgery.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Intervention Description
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Primary Outcome Measure Information:
Title
Change from Baseline Ocular Surface Disease Index at 1 week
Description
Ocular Surface Disease Index
Time Frame
0 day, 1 week postoperative
Title
Change from Baseline Ocular Surface Disease Index at 1 month
Description
Ocular Surface Disease Index
Time Frame
0 day, 1 month postoperative
Title
Change from Baseline meibography score at 1 week
Description
meibography score
Time Frame
0 day, 1 week postoperative
Title
Change from Baseline meibography score at 1 month
Description
meibography score
Time Frame
0 day, 1 month postoperative
Title
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
Description
non-invasive keratograph tear meniscus height
Time Frame
0 day, 1 month postoperative
Title
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
Description
non-invasive keratograph tear meniscus height
Time Frame
0 day, 1 week postoperative
Title
Change from Baseline noninvasive tear breakup time at 1 week
Description
noninvasive tear breakup time
Time Frame
0 day, 1 week postoperative
Title
Change from Baseline noninvasive tear breakup time at 1 month
Description
noninvasive tear breakup time
Time Frame
0 day, 1 month postoperative
Title
Change from Baseline Schirmer I test at 1 week
Description
Schirmer I test
Time Frame
0 day, 1 week postoperative
Title
Change from Baseline Schirmer I test at 1 month
Description
Schirmer I test
Time Frame
0 day, 1 month postoperative
Title
slit-lamp examination
Description
slit-lamp examination
Time Frame
0 day
Title
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
Description
cytokine levels
Time Frame
0 day and 1 month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age-related cataract dry eye disease Exclusion Criteria: a history of surgery and other ocular diseases contact lens use 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.
Facility Information:
Facility Name
Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33507461
Citation
Wu X, Ma Y, Chen X, He S, Lin X, Yu X, Chen W, Luo C, Xu W. Efficacy of bandage contact lens for the management of dry eye disease after cataract surgery. Int Ophthalmol. 2021 Apr;41(4):1403-1413. doi: 10.1007/s10792-021-01692-6. Epub 2021 Jan 28.
Results Reference
derived

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

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