Clinical trial NCT04120389: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lens Subluxation
Hypermature Cataract
Corneal Opacity
Small Pupil
Keywords: Bandage contact lens
cataract surgery
dry eye
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Ocular Surface Disease Index questionnaire
timeFrame: 0 day preoperatively
measure: Ocular Surface Disease Index questionnaire
timeFrame: 1 day postoperatively
measure: Ocular Surface Disease Index questionnaire
timeFrame: 1 week postoperatively
measure: Ocular Surface Disease Index questionnaire
timeFrame: 1 month postoperatively
measure: Ocular Surface Disease Index questionnaire
timeFrame: 3 months postoperatively
measure: Tear Breakup Time
timeFrame: 0 day preoperatively
measure: Tear Breakup Time
timeFrame: 1 week postoperatively
measure: Tear Breakup Time
timeFrame: 1 month postoperatively
measure: Tear Breakup Time
timeFrame: 3 months postoperatively
measure: Schirmer test with anesthesia
timeFrame: 0 day preoperatively
measure: Schirmer test with anesthesia
timeFrame: 1 week postoperatively
measure: Schirmer test with anesthesia
timeFrame: 1 month postoperatively
measure: Schirmer test with anesthesia
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Subjective symptoms
timeFrame: 0 day preoperatively
measure: Subjective symptoms
timeFrame: 1 day postoperatively
measure: Subjective symptoms
timeFrame: 1 week postoperatively
measure: Subjective symptoms
timeFrame: 1 month postoperatively
measure: Subjective symptoms
timeFrame: 3 months postoperatively
measure: Fluorescein Staining
timeFrame: 0 day preoperatively
measure: Fluorescein Staining
timeFrame: 1 week postoperatively
measure: Fluorescein Staining
timeFrame: 1 month postoperatively
measure: Fluorescein Staining
timeFrame: 3 months postoperatively
Other outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 0 day preoperatively
measure: Best Corrected Visual Acuity
timeFrame: 1 day postoperatively
measure: Best Corrected Visual Acuity
timeFrame: 1 week postoperatively
measure: Best Corrected Visual Acuity
timeFrame: 1 month postoperatively
measure: Best Corrected Visual Acuity
timeFrame: 3 months postoperatively
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: