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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100031
• Other study ID #: xuwen2018-082
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 6, 2020

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 6, 2020
• Est. primary completion date: December 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• bandage contact lenses
wear bandage contact lensesfor a week after cataract surgery.

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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