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

Study Overview
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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

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

Conditions
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Cataract, Dry Eye

Intervention / Treatment
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* Device: bandage contact lenses
* Procedure: phacoemulsification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCL group<br> | Device: bandage contact lenses<br>* wear bandage contact lensesfor a week after cataract surgery.<br>Procedure: phacoemulsification<br>* underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens<br>|
| Active Comparator: control group<br> | Procedure: phacoemulsification<br>* underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |