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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04100031
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.2
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract; Dry Eye	Device: bandage contact lenses; Procedure: phacoemulsification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Dec 6, 2020
• Actual Study Completion Date: Dec 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BCL group	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
Active Comparator: control group	Procedure: phacoemulsification; underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Ocular Surface Disease Index at 1 week [0 day, 1 week postoperative]

   Ocular Surface Disease Index

2. Change from Baseline Ocular Surface Disease Index at 1 month [0 day, 1 month postoperative]

   Ocular Surface Disease Index

3. Change from Baseline meibography score at 1 week [0 day, 1 week postoperative]

   meibography score

4. Change from Baseline meibography score at 1 month [0 day, 1 month postoperative]

   meibography score

5. Change from Baseline of non-invasive keratograph tear meniscus height at 1 month [0 day, 1 month postoperative]

   non-invasive keratograph tear meniscus height

6. Change from Baseline of non-invasive keratograph tear meniscus height at 1 week [0 day, 1 week postoperative]

   non-invasive keratograph tear meniscus height

7. Change from Baseline noninvasive tear breakup time at 1 week [0 day, 1 week postoperative]

   noninvasive tear breakup time

8. Change from Baseline noninvasive tear breakup time at 1 month [0 day, 1 month postoperative]

   noninvasive tear breakup time

9. Change from Baseline Schirmer I test at 1 week [0 day, 1 week postoperative]

   Schirmer I test

10. Change from Baseline Schirmer I test at 1 month [0 day, 1 month postoperative]

    Schirmer I test

11. slit-lamp examination [0 day]

    slit-lamp examination

12. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04100031
• Other Study ID Numbers: xuwen2018-082
• First Posted: Sep 23, 2019
• Last Update Posted: Apr 5, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Capsule Opacification

Study Results

No Results Posted as of Apr 5, 2021