Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined 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 complicated and combined cataract surgery

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

Conditions
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Lens Subluxation, Cataract, Hypermature Cataract, Corneal Opacity, Small Pupil

Intervention / Treatment
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* Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
* Procedure: phacoemulsification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCL group<br>bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) | Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)<br>* wear an bandage contact lenses for a week after Complicated and Combined 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 |
| --- | --- | --- |
| Ocular Surface Disease Index questionnaire | Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4 | 0 day preoperatively | 
| Ocular Surface Disease Index questionnaire | Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4 | 1 day postoperatively | 
| Ocular Surface Disease Index questionnaire | Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4 | 1 week postoperatively | 
| Ocular Surface Disease Index questionnaire | Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4 | 1 month postoperatively | 
| Ocular Surface Disease Index questionnaire | Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4 | 3 months postoperatively | 
| Tear Breakup Time | Tear Breakup Time was performed to assess tear film stability | 0 day preoperatively | 
| Tear Breakup Time | Tear Breakup Time was performed to assess tear film stability | 1 week postoperatively | 
| Tear Breakup Time | Tear Breakup Time was performed to assess tear film stability | 1 month postoperatively | 
| Tear Breakup Time | Tear Breakup Time was performed to assess tear film stability | 3 months postoperatively | 
| Schirmer test with anesthesia | The Schirmer test was performed by inserting a test strip | 0 day preoperatively | 
| Schirmer test with anesthesia | The Schirmer test was performed by inserting a test strip | 1 week postoperatively | 
| Schirmer test with anesthesia | The Schirmer test was performed by inserting a test strip | 1 month postoperatively | 
| Schirmer test with anesthesia | The Schirmer test was performed by inserting a test strip | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptoms | Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always | 0 day preoperatively | 
| Subjective symptoms | Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always | 1 day postoperatively | 
| Subjective symptoms | Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always | 1 week postoperatively | 
| Subjective symptoms | Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always | 1 month postoperatively | 
| Subjective symptoms | Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always | 3 months postoperatively | 
| Fluorescein Staining | The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye | 0 day preoperatively | 
| Fluorescein Staining | The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye | 1 week postoperatively | 
| Fluorescein Staining | The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye | 1 month postoperatively | 
| Fluorescein Staining | The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, Bandage contact lens, cataract surgery