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

Not Applicable

• Conditions: Cataract; Corneal Opacity; Lens Subluxation; Hypermature Cataract; Small Pupil
• Interventions: Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY); Procedure: phacoemulsification

• Registration Number: NCT04120389
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2020-03-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCL group	bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)	bandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY)
BCL group	phacoemulsification	bandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY)
control group	phacoemulsification	-

Primary Outcome Measures

Name	Time	Method
Schirmer test with anesthesia	3 months postoperatively	The Schirmer test was performed by inserting a test strip
Tear Breakup Time	3 months postoperatively	Tear Breakup Time was performed to assess tear film stability
Ocular Surface Disease Index questionnaire	3 months postoperatively	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4

Secondary Outcome Measures

Name	Time	Method
Fluorescein Staining	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
Subjective symptoms	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

Trial Locations

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China