Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BCL group bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) |
Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)
wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.
Procedure: phacoemulsification
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
|
| Active Comparator: control group
|
Procedure: phacoemulsification
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
|
Outcome Measures
Primary Outcome Measures
- Ocular Surface Disease Index questionnaire [0 day preoperatively]
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
- Ocular Surface Disease Index questionnaire [1 day postoperatively]
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
- Ocular Surface Disease Index questionnaire [1 week postoperatively]
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
- Ocular Surface Disease Index questionnaire [1 month postoperatively]
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
- Ocular Surface Disease Index questionnaire [3 months postoperatively]
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
- Tear Breakup Time [0 day preoperatively]
Tear Breakup Time was performed to assess tear film stability
- Tear Breakup Time [1 week postoperatively]
Tear Breakup Time was performed to assess tear film stability
- Tear Breakup Time [1 month postoperatively]
Tear Breakup Time was performed to assess tear film stability
- Tear Breakup Time [3 months postoperatively]
Tear Breakup Time was performed to assess tear film stability
- Schirmer test with anesthesia [0 day preoperatively]
The Schirmer test was performed by inserting a test strip
- Schirmer test with anesthesia [1 week postoperatively]
The Schirmer test was performed by inserting a test strip
- Schirmer test with anesthesia [1 month postoperatively]
The Schirmer test was performed by inserting a test strip
- Schirmer test with anesthesia [3 months postoperatively]
The Schirmer test was performed by inserting a test strip
Secondary Outcome Measures
- Subjective symptoms [0 day preoperatively]
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
- Subjective symptoms [1 day postoperatively]
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
- Subjective symptoms [1 week postoperatively]
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
- Subjective symptoms [1 month postoperatively]
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
- Subjective symptoms [3 months postoperatively]
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
- Fluorescein Staining [0 day preoperatively]
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 [1 week postoperatively]
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 [1 month postoperatively]
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 [3 months postoperatively]
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
Other Outcome Measures
- Best Corrected Visual Acuity [0 day preoperatively]
The BCVA was measured by the same optometrist at each visit
- Best Corrected Visual Acuity [1 day postoperatively]
The BCVA was measured by the same optometrist at each visit
- Best Corrected Visual Acuity [1 week postoperatively]
The BCVA was measured by the same optometrist at each visit
- Best Corrected Visual Acuity [1 month postoperatively]
The BCVA was measured by the same optometrist at each visit
- Best Corrected Visual Acuity [3 months postoperatively]
The BCVA was measured by the same optometrist at each visit
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- xuwen2019-929