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

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ClinicalTrials.gov Identifier: NCT04120389
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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
Complicated and Combined Cataract Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) Procedure: phacoemulsification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Wear

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




Primary Outcome Measures :
  1. Ocular Surface Disease Index questionnaire [ Time Frame: 0 day preoperatively ]
    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

  2. Ocular Surface Disease Index questionnaire [ Time Frame: 1 day postoperatively ]
    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

  3. Ocular Surface Disease Index questionnaire [ Time Frame: 1 week postoperatively ]
    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

  4. Ocular Surface Disease Index questionnaire [ Time Frame: 1 month postoperatively ]
    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

  5. Ocular Surface Disease Index questionnaire [ Time Frame: 3 months postoperatively ]
    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

  6. Tear Breakup Time [ Time Frame: 0 day preoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  7. Tear Breakup Time [ Time Frame: 1 week postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  8. Tear Breakup Time [ Time Frame: 1 month postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  9. Tear Breakup Time [ Time Frame: 3 months postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  10. Schirmer test with anesthesia [ Time Frame: 0 day preoperatively ]
    The Schirmer test was performed by inserting a test strip

  11. Schirmer test with anesthesia [ Time Frame: 1 week postoperatively ]
    The Schirmer test was performed by inserting a test strip

  12. Schirmer test with anesthesia [ Time Frame: 1 month postoperatively ]
    The Schirmer test was performed by inserting a test strip

  13. Schirmer test with anesthesia [ Time Frame: 3 months postoperatively ]
    The Schirmer test was performed by inserting a test strip


Secondary Outcome Measures :
  1. Subjective symptoms [ Time Frame: 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

  2. Subjective symptoms [ Time Frame: 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

  3. Subjective symptoms [ Time Frame: 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

  4. Subjective symptoms [ Time Frame: 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

  5. Subjective symptoms [ Time Frame: 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

  6. Fluorescein Staining [ Time Frame: 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

  7. Fluorescein Staining [ Time Frame: 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

  8. Fluorescein Staining [ Time Frame: 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

  9. Fluorescein Staining [ Time Frame: 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:
  1. Best Corrected Visual Acuity [ Time Frame: 0 day preoperatively ]
    The BCVA was measured by the same optometrist at each visit

  2. Best Corrected Visual Acuity [ Time Frame: 1 day postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  3. Best Corrected Visual Acuity [ Time Frame: 1 week postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  4. Best Corrected Visual Acuity [ Time Frame: 1 month postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  5. Best Corrected Visual Acuity [ Time Frame: 3 months postoperatively ]
    The BCVA was measured by the same optometrist at each visit



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120389


Contacts
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Contact: wen xu, PHD +86 571 87783897 xuwen2003@zju.edu.cn

Locations
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China, Zhejiang
Second Affiliated Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: wen xu, PHD    +86 571 87783897    xuwen2003@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04120389     History of Changes
Other Study ID Numbers: xuwen2019-929
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Bandage contact lens
cataract surgery
dry eye
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases