Back to resultsEfficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Primary Purpose
Cataract, Lens Subluxation, Hypermature Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Bandage contact lens, cataract surgery, dry eye
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
Sites / Locations
- Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BCL group
control group
Arm Description
bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Secondary Outcome Measures
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
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
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
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
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
Full Information
NCT ID
NCT04120389
First Posted
September 29, 2019
Last Updated
April 2, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04120389
Brief Title
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Official Title
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Subluxation, Hypermature Cataract, Corneal Opacity, Small Pupil
Keywords
Bandage contact lens, cataract surgery, dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BCL group
Arm Type
Experimental
Arm Description
bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
Intervention Description
wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Intervention Description
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index questionnaire
Description
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Time Frame
0 day preoperatively
Title
Ocular Surface Disease Index questionnaire
Description
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Time Frame
1 day postoperatively
Title
Ocular Surface Disease Index questionnaire
Description
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Time Frame
1 week postoperatively
Title
Ocular Surface Disease Index questionnaire
Description
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Time Frame
1 month postoperatively
Title
Ocular Surface Disease Index questionnaire
Description
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Time Frame
3 months postoperatively
Title
Tear Breakup Time
Description
Tear Breakup Time was performed to assess tear film stability
Time Frame
0 day preoperatively
Title
Tear Breakup Time
Description
Tear Breakup Time was performed to assess tear film stability
Time Frame
1 week postoperatively
Title
Tear Breakup Time
Description
Tear Breakup Time was performed to assess tear film stability
Time Frame
1 month postoperatively
Title
Tear Breakup Time
Description
Tear Breakup Time was performed to assess tear film stability
Time Frame
3 months postoperatively
Title
Schirmer test with anesthesia
Description
The Schirmer test was performed by inserting a test strip
Time Frame
0 day preoperatively
Title
Schirmer test with anesthesia
Description
The Schirmer test was performed by inserting a test strip
Time Frame
1 week postoperatively
Title
Schirmer test with anesthesia
Description
The Schirmer test was performed by inserting a test strip
Time Frame
1 month postoperatively
Title
Schirmer test with anesthesia
Description
The Schirmer test was performed by inserting a test strip
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Subjective symptoms
Description
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Time Frame
0 day preoperatively
Title
Subjective symptoms
Description
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Time Frame
1 day postoperatively
Title
Subjective symptoms
Description
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Time Frame
1 week postoperatively
Title
Subjective symptoms
Description
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Time Frame
1 month postoperatively
Title
Subjective symptoms
Description
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Time Frame
3 months postoperatively
Title
Fluorescein Staining
Description
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
Time Frame
0 day preoperatively
Title
Fluorescein Staining
Description
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
Time Frame
1 week postoperatively
Title
Fluorescein Staining
Description
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
Time Frame
1 month postoperatively
Title
Fluorescein Staining
Description
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
Time Frame
3 months postoperatively
Other Pre-specified Outcome Measures:
Title
Best Corrected Visual Acuity
Description
The BCVA was measured by the same optometrist at each visit
Time Frame
0 day preoperatively
Title
Best Corrected Visual Acuity
Description
The BCVA was measured by the same optometrist at each visit
Time Frame
1 day postoperatively
Title
Best Corrected Visual Acuity
Description
The BCVA was measured by the same optometrist at each visit
Time Frame
1 week postoperatively
Title
Best Corrected Visual Acuity
Description
The BCVA was measured by the same optometrist at each visit
Time Frame
1 month postoperatively
Title
Best Corrected Visual Acuity
Description
The BCVA was measured by the same optometrist at each visit
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wen xu, PHD
Phone
+86 571 87783897
Email
xuwen2003@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wen xu, PHD
Phone
+86 571 87783897
Email
xuwen2003@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
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