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

April 2, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tear Breakup Time
Time Frame: 1 week postoperatively
Tear Breakup Time was performed to assess tear film stability
1 week postoperatively
Tear Breakup Time
Time Frame: 1 month postoperatively
Tear Breakup Time was performed to assess tear film stability
1 month postoperatively
Tear Breakup Time
Time Frame: 3 months postoperatively
Tear Breakup Time was performed to assess tear film stability
3 months postoperatively
Ocular Surface Disease Index questionnaire
Time Frame: 0 day preoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
0 day preoperatively
Ocular Surface Disease Index questionnaire
Time Frame: 1 day postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
1 day postoperatively
Ocular Surface Disease Index questionnaire
Time Frame: 1 week postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
1 week postoperatively
Ocular Surface Disease Index questionnaire
Time Frame: 1 month postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
1 month postoperatively
Ocular Surface Disease Index questionnaire
Time Frame: 3 months postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
3 months postoperatively
Tear Breakup Time
Time Frame: 0 day preoperatively
Tear Breakup Time was performed to assess tear film stability
0 day preoperatively
Schirmer test with anesthesia
Time Frame: 0 day preoperatively
The Schirmer test was performed by inserting a test strip
0 day preoperatively
Schirmer test with anesthesia
Time Frame: 1 week postoperatively
The Schirmer test was performed by inserting a test strip
1 week postoperatively
Schirmer test with anesthesia
Time Frame: 1 month postoperatively
The Schirmer test was performed by inserting a test strip
1 month postoperatively
Schirmer test with anesthesia
Time Frame: 3 months postoperatively
The Schirmer test was performed by inserting a test strip
3 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective symptoms
Time Frame: 0 day preoperatively
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
Time Frame: 1 day postoperatively
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
Time Frame: 1 week postoperatively
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
Time Frame: 1 month postoperatively
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
Time Frame: 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
3 months postoperatively
Fluorescein Staining
Time Frame: 0 day preoperatively
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
Time Frame: 1 week 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
1 week postoperatively
Fluorescein Staining
Time Frame: 1 month 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
1 month postoperatively
Fluorescein Staining
Time Frame: 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
3 months postoperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: 1 week postoperatively
The BCVA was measured by the same optometrist at each visit
1 week postoperatively
Best Corrected Visual Acuity
Time Frame: 1 month postoperatively
The BCVA was measured by the same optometrist at each visit
1 month postoperatively
Best Corrected Visual Acuity
Time Frame: 3 months postoperatively
The BCVA was measured by the same optometrist at each visit
3 months postoperatively
Best Corrected Visual Acuity
Time Frame: 0 day preoperatively
The BCVA was measured by the same optometrist at each visit
0 day preoperatively
Best Corrected Visual Acuity
Time Frame: 1 day postoperatively
The BCVA was measured by the same optometrist at each visit
1 day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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