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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04100031
Enrollment
140
Registered
2019-09-23
Start date
2018-09-01
Completion date
2020-12-06
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Dry Eye

Brief summary

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

Interventions

DEVICEbandage contact lenses

wear bandage contact lensesfor a week after cataract surgery.

PROCEDUREphacoemulsification

underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age-related cataract 2. dry eye disease

Exclusion criteria

1. a history of surgery and other ocular diseases 2. contact lens use 3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.

Design outcomes

Primary

MeasureTime frameDescription
slit-lamp examination0 dayslit-lamp examination
Change from Baseline Ocular Surface Disease Index at 1 week0 day, 1 week postoperativeOcular Surface Disease Index
Change from Baseline Ocular Surface Disease Index at 1 month0 day, 1 month postoperativeOcular Surface Disease Index
Change from Baseline meibography score at 1 week0 day, 1 week postoperativemeibography score
Change from Baseline meibography score at 1 month0 day, 1 month postoperativemeibography score
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month0 day, 1 month postoperativenon-invasive keratograph tear meniscus height
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week0 day, 1 week postoperativenon-invasive keratograph tear meniscus height
Change from Baseline noninvasive tear breakup time at 1 week0 day, 1 week postoperativenoninvasive tear breakup time
Change from Baseline noninvasive tear breakup time at 1 month0 day, 1 month postoperativenoninvasive tear breakup time
Change from Baseline Schirmer I test at 1 week0 day, 1 week postoperativeSchirmer I test
Change from Baseline Schirmer I test at 1 month0 day, 1 month postoperativeSchirmer I test
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month0 day and 1 month postoperativecytokine levels

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026