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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wen Xu, PHD; Phone Number: +86 571 87783897; Email: xuwen2003@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: wen Xu, PHD; Phone Number: +86 571 87783897; Email: xuwen2003@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Procedure: phacoemulsification; underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
Experimental: BCL group; bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)	Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY); wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.; Procedure: phacoemulsification; underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 week postoperatively
Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 month postoperatively
Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	3 months postoperatively
Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4	0 day preoperatively
Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4	1 day postoperatively
Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4	1 week postoperatively
Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4	1 month postoperatively
Ocular Surface Disease Index questionnaire	Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4	3 months postoperatively
Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	0 day preoperatively
Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	0 day preoperatively
Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	1 week postoperatively
Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	1 month postoperatively
Schirmer test with anesthesia	The Schirmer test was performed by inserting a test strip	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective symptoms	Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always	0 day preoperatively
Subjective symptoms	Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always	1 day postoperatively
Subjective symptoms	Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always	1 week postoperatively
Subjective symptoms	Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always	1 month postoperatively
Subjective symptoms	Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always	3 months postoperatively
Fluorescein Staining	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	0 day preoperatively
Fluorescein Staining	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	1 week postoperatively
Fluorescein Staining	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	1 month postoperatively
Fluorescein Staining	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	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 week postoperatively
Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 month postoperatively
Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	3 months postoperatively
Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	0 day preoperatively
Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 day postoperatively

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: cataract surgery; dry eye; Bandage contact lens
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lens Diseases; Lacrimal Apparatus Diseases; Corneal Diseases; Pupil Disorders; Cataract; Dry Eye Syndromes; Corneal Opacity; Lens Subluxation; Miosis
• Other Study ID Numbers: xuwen2019-929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No