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

Not Applicable

Completed

• Conditions: Cataract; Dry Eye
• Interventions: Device: bandage contact lenses; Procedure: phacoemulsification

• Registration Number: NCT04100031
• 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 cataract surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Primary Completion: 2020-12-06
• Study Completion: 2020-12-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCL group	phacoemulsification	-
control group	phacoemulsification	-
BCL group	bandage contact lenses	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline meibography score at 1 week	0 day, 1 week postoperative	meibography score
Change from Baseline noninvasive tear breakup time at 1 week	0 day, 1 week postoperative	noninvasive tear breakup time
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month	0 day, 1 month postoperative	non-invasive keratograph tear meniscus height
Change from Baseline meibography score at 1 month	0 day, 1 month postoperative	meibography score
Change from Baseline noninvasive tear breakup time at 1 month	0 day, 1 month postoperative	noninvasive tear breakup time
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month	0 day and 1 month postoperative	cytokine levels
Change from Baseline Ocular Surface Disease Index at 1 week	0 day, 1 week postoperative	Ocular Surface Disease Index
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week	0 day, 1 week postoperative	non-invasive keratograph tear meniscus height
Change from Baseline Schirmer I test at 1 week	0 day, 1 week postoperative	Schirmer I test
Change from Baseline Ocular Surface Disease Index at 1 month	0 day, 1 month postoperative	Ocular Surface Disease Index
Change from Baseline Schirmer I test at 1 month	0 day, 1 month postoperative	Schirmer I test
slit-lamp examination	0 day	slit-lamp examination

Trial Locations

Locations (1)

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