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

NCT ID: NCT04100031

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-06

Brief Summary

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

Detailed Description

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Conditions

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Cataract Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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BCL group

Group Type EXPERIMENTAL

bandage contact lenses

Intervention Type DEVICE

wear bandage contact lensesfor a week after cataract surgery.

phacoemulsification

Intervention Type PROCEDURE

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

control group

Group Type ACTIVE_COMPARATOR

phacoemulsification

Intervention Type PROCEDURE

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

Interventions

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bandage contact lenses

wear bandage contact lensesfor a week after cataract surgery.

Intervention Type DEVICE

phacoemulsification

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33507461 (View on PubMed)

Other Identifiers

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xuwen2018-082

Identifier Type: -

Identifier Source: org_study_id

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