Skip to main content
OpenTrials
Completed

NCT Number: NCT04100031

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bandage contact lenses

Device

wear bandage contact lensesfor a week after cataract surgery.

phacoemulsification

Procedure

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

Primary outcomes

  1. Change from Baseline Ocular Surface Disease Index at 1 week

    Time frame: 0 day, 1 week postoperative

    Ocular Surface Disease Index

  2. Change from Baseline Ocular Surface Disease Index at 1 month

    Time frame: 0 day, 1 month postoperative

    Ocular Surface Disease Index

  3. Change from Baseline meibography score at 1 week

    Time frame: 0 day, 1 week postoperative

    meibography score

  4. Change from Baseline meibography score at 1 month

    Time frame: 0 day, 1 month postoperative

    meibography score

  5. 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

  6. 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

  7. Change from Baseline noninvasive tear breakup time at 1 week

    Time frame: 0 day, 1 week postoperative

    noninvasive tear breakup time

  8. Change from Baseline noninvasive tear breakup time at 1 month

    Time frame: 0 day, 1 month postoperative

    noninvasive tear breakup time

  9. Change from Baseline Schirmer I test at 1 week

    Time frame: 0 day, 1 week postoperative

    Schirmer I test

  10. Change from Baseline Schirmer I test at 1 month

    Time frame: 0 day, 1 month postoperative

    Schirmer I test

  11. slit-lamp examination

    Time frame: 0 day

    slit-lamp examination

  12. 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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2019
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.