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

NCT ID: NCT04120389

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Cataract Lens Subluxation Hypermature Cataract Corneal Opacity Small Pupil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BCL group

bandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY)

Group Type EXPERIMENTAL

bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)

Intervention Type DEVICE

wear an bandage contact lenses for a week after Complicated and Combined 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(PureVision; Bausch & Lomb Inc., Rochester, NY)

wear an bandage contact lenses for a week after Complicated and Combined 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. cataract patients(age 40-80)
2. complex symptom(such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc)
3. dry eye disease

Exclusion Criteria

1. simplex age-related cataract
2. contact lens use
3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
4. any systemic diseases such as heart diseases, diabetes and psychosis
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 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 RECRUITING

Countries

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China

Central Contacts

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wen xu, PHD

Role: CONTACT

+86 571 87783897

Facility Contacts

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wen xu, PHD

Role: primary

+86 571 87783897

References

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Chen D, Xu D, Wu X, Wang J, Sheng S, Yu X, Lin X, Liu L, Ge X, Zhao H, Xu W. The efficacy of bandage contact lens in relieving the aggravation of dry eye disease after complicated cataract or/and IOL surgery. BMC Ophthalmol. 2024 Mar 28;24(1):141. doi: 10.1186/s12886-024-03385-x.

Reference Type DERIVED
PMID: 38549070 (View on PubMed)

Other Identifiers

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xuwen2019-929

Identifier Type: -

Identifier Source: org_study_id

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