NCT04100031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2020

Completed
Last Updated

April 5, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

September 18, 2019

Last Update Submit

April 2, 2021

Conditions

CataractDry Eye

Outcome Measures

Primary Outcomes (12)

  • Change from Baseline Ocular Surface Disease Index at 1 week

    Ocular Surface Disease Index

    0 day, 1 week postoperative

  • Change from Baseline Ocular Surface Disease Index at 1 month

    Ocular Surface Disease Index

    0 day, 1 month postoperative

  • Change from Baseline meibography score at 1 week

    meibography score

    0 day, 1 week postoperative

  • Change from Baseline meibography score at 1 month

    meibography score

    0 day, 1 month postoperative

  • Change from Baseline of non-invasive keratograph tear meniscus height at 1 month

    non-invasive keratograph tear meniscus height

    0 day, 1 month postoperative

  • Change from Baseline of non-invasive keratograph tear meniscus height at 1 week

    non-invasive keratograph tear meniscus height

    0 day, 1 week postoperative

  • Change from Baseline noninvasive tear breakup time at 1 week

    noninvasive tear breakup time

    0 day, 1 week postoperative

  • Change from Baseline noninvasive tear breakup time at 1 month

    noninvasive tear breakup time

    0 day, 1 month postoperative

  • Change from Baseline Schirmer I test at 1 week

    Schirmer I test

    0 day, 1 week postoperative

  • Change from Baseline Schirmer I test at 1 month

    Schirmer I test

    0 day, 1 month postoperative

  • slit-lamp examination

    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

    cytokine levels

    0 day and 1 month postoperative

Study Arms (2)

BCL group

EXPERIMENTAL
Device: bandage contact lensesProcedure: phacoemulsification

control group

ACTIVE COMPARATOR
Procedure: phacoemulsification

Interventions

bandage contact lensesDEVICE

wear bandage contact lensesfor a week after cataract surgery.

BCL group
phacoemulsificationPROCEDURE

underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens

BCL groupcontrol group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age-related cataract
  • dry eye disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

  • 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.

    PMID: 33507461DERIVED

MeSH Terms

Conditions

CataractDry Eye Syndromes

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

September 1, 2018

Primary Completion

December 6, 2020

Study Completion

December 6, 2020

Last Updated

April 5, 2021

Record last verified: 2021-01

Locations

CN(1)