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Clinical Trials/NCT04120389
NCT04120389
Unknown
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country30 target enrollmentMarch 13, 2020
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ConditionsCataractLens SubluxationHypermature CataractCorneal OpacitySmall Pupil

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
30
Locations
1
Primary Endpoint
Schirmer test with anesthesia
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 13, 2020
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •cataract patients（age 40-80）
  • •complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc）
  • •dry eye disease

Exclusion Criteria

  • •simplex age-related cataract
  • •contact lens use
  • •ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
  • •any systemic diseases such as heart diseases, diabetes and psychosis

Outcomes

Primary Outcomes

Schirmer test with anesthesia

Time Frame: 3 months postoperatively

The Schirmer test was performed by inserting a test strip

Tear Breakup Time

Time Frame: 3 months postoperatively

Tear Breakup Time was performed to assess tear film stability

Ocular Surface Disease Index questionnaire

Time Frame: 3 months postoperatively

Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4

Secondary Outcomes

  • Fluorescein Staining(3 months postoperatively)
  • Subjective symptoms(3 months postoperatively)

Study Sites (1)

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