Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract

July 20, 2021 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

Comparison of Intraocular Caliper-assisted and Verion Navigation System-assisted Capsulotomy in Phacoemulsification Surgery: A Randomized Non-inferiority Trial

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality of patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. However, most surgeons perform CCC by experience or referring to the pupil size, which is highly subjective and the accuracy of capsulorhexis is unsatisfactory. The investigators developed a new modified intraocular caliper with standard calibration on the rinse needle, which can measure and locate the position of capsulorhexis. The surgeon can gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. We found intraocular caliper-assisted capsulotomy can obviously improve the accuracy of capsulorhexis. The purpose of this study is to compare the accuracy and postoperative visual quality of intraocular caliper-assisted capsulotomy with those of digital image projection device VERION navigation system.

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.
156

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 Locations

  • China
      • Guangzhou, China, 510060
        • Zhongshan Ophthalmic Center,Sun Yat-Sen University

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

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 55 to 80 years with age-related cataract;
  • Pupil diameter ≥ 6.5mm after pupil dilation;
  • Lens nuclear opacity grading score (LOCS III) lower than 4.0.

Exclusion Criteria:

  • Patients had previous intraocular surgery;
  • Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
  • Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
  • Refused to participate the study.

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: Other
  • 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.
Experimental: Intraocular caliper-assisted capsulotomy group
In intraocular caliper-assisted capsulotomy group, a modified intraocular caliper with standard calibration on the rinse needle was used to measure and locate the position of capsulorhexis with 5.3 mm diameter and the principle of pupillary margin in concentric circles. The surgeon could gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks.
Procedure: Intraocular caliper-assisted capsulotomy
Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
Active Comparator: Verion navigation system-assisted capsulotomy group
In the Verion-assisted capsulotomy group, Verion navigation system was applied to project a 5.3 mm capsulorhexis centered on the corneal vertex. According to the projected capsulorhexis, capsulotomy was performed.
Procedure: Verion navigation system-assisted capsulotomy
Verion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter.

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
Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
Time Frame: During the surgery
Images of the edges of IOL and capsulorhexis are taken at the end of the operation. Image J image analysis software is used to measure the horizontal diameter and vertical diameter of capsulorhexis with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime, and further calculate the deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm) .
During the surgery

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
Uncorrected and corrected visual acuity
Time Frame: One month after surgery
Visual acuity is evaluated with ETDRS visual acuity chart.
One month after surgery
Ideal ratio of capsulorhexis
Time Frame: During the surgery
Ideal capsulorhexis is defined as a centered and round capsulorhexis, which can cover the edge of IOL optical surface continuously for 360 degrees with a diameter between 5.0 to 5.5 mm.
During the surgery
Grades of capsulorhexis-IOL overlap
Time Frame: During the surgery
The capsulorhexis-IOL overlap of each patient is graded as 360-degree continuous overlap, 270~360-degree overlap, 180~270-degree overlap, 90~180-degree overlap, and < 90-degree overlap.
During the surgery
Distance between pupil center and capsulorhexis center
Time Frame: During the surgery
Measured by Image J image analysis software.
During the surgery
Horizontal and vertical diameter of capsulorhexis
Time Frame: During the surgery
Measured by Image J image analysis software.
During the surgery
Intraocular lens tilt
Time Frame: One month after surgery
Measured by anterior segment OCT (CASIA2).
One month after surgery
Intraocular lens decentration
Time Frame: One month after surgery
Measured by anterior segment OCT (CASIA2).
One month after surgery
Intraocular aberrations
Time Frame: One month after surgery
Measured by OPD-SCAN III.
One month after surgery
Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
Time Frame: One month after surgery
One month after surgery

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.
Zhongshan Ophthalmic Center, Sun Yat-sen 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 (Anticipated)

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.
July 26, 2021

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.
February 28, 2022

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.
April 30, 2022

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).
July 15, 2021

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.
July 20, 2021

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.
July 26, 2021

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.
July 26, 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.
July 20, 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.
July 1, 2021

More Information

Terms related to this study

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.
  • 2021KYPJ110

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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