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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04120389
• Other study ID #: xuwen2019-929
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: wen xu, PHD
• Phone: +86 571 87783897
• Email: xuwen2003[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Corneal Opacity
• Hypermature Cataract
• Lens Subluxation
• Miosis
• Small Pupil

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	0 day preoperatively
Other	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 day postoperatively
Other	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 week postoperatively
Other	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 month postoperatively
Other	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	3 months postoperatively
Primary	Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4	0 day preoperatively
Primary	Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4	1 day postoperatively
Primary	Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4	1 week postoperatively
Primary	Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4	1 month postoperatively
Primary	Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4	3 months postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	0 day preoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 week postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 month postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	3 months postoperatively
Primary	Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	0 day preoperatively
Primary	Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	1 week postoperatively
Primary	Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	1 month postoperatively
Primary	Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	3 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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