Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 5, 2021
January 1, 2021
1.8 years
September 29, 2019
April 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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 Outcomes (9)
Subjective symptoms
0 day preoperatively
Subjective symptoms
1 day postoperatively
Subjective symptoms
1 week postoperatively
Subjective symptoms
1 month postoperatively
Subjective symptoms
3 months postoperatively
- +4 more secondary outcomes
Other Outcomes (5)
Best Corrected Visual Acuity
0 day preoperatively
Best Corrected Visual Acuity
1 day postoperatively
Best Corrected Visual Acuity
1 week postoperatively
- +2 more other outcomes
Study Arms (2)
BCL group
EXPERIMENTALbandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY)
control group
ACTIVE COMPARATORInterventions
wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Related Publications (1)
Chen D, Xu D, Wu X, Wang J, Sheng S, Yu X, Lin X, Liu L, Ge X, Zhao H, Xu W. The efficacy of bandage contact lens in relieving the aggravation of dry eye disease after complicated cataract or/and IOL surgery. BMC Ophthalmol. 2024 Mar 28;24(1):141. doi: 10.1186/s12886-024-03385-x.
PMID: 38549070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2019
First Posted
October 9, 2019
Study Start
March 13, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
April 5, 2021
Record last verified: 2021-01