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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04120389
Enrollment
30
Registered
2019-10-09
Start date
2020-03-13
Completion date
2021-12-31
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, Corneal Opacity, Hypermature Cataract, Lens Subluxation, Small Pupil

Keywords

Bandage contact lens, cataract surgery, dry eye

Brief summary

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

Interventions

DEVICEbandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)

wear an bandage contact lenses for a week after Complicated and Combined 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
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ocular Surface Disease Index questionnaire0 day preoperativelyOcular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4
Tear Breakup Time0 day preoperativelyTear Breakup Time was performed to assess tear film stability
Schirmer test with anesthesia0 day preoperativelyThe Schirmer test was performed by inserting a test strip

Secondary

MeasureTime frameDescription
Subjective symptoms0 day preoperativelySubjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always
Fluorescein Staining0 day preoperativelyThe 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

MeasureTime frameDescription
Best Corrected Visual Acuity0 day preoperativelyThe BCVA was measured by the same optometrist at each visit

Countries

China

Contacts

Primary Contactwen xu, PHD
xuwen2003@zju.edu.cn+86 571 87783897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026