Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients

May 6, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment.

Study Overview

Status

Status

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

Detailed Description

Based on the existing cataract surgery methods, through prospective follow-up study, this study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intends to further improve the quality of Clinical Cataract diagnosis and treatment.

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.
Observational

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.
1000

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

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

2 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University

Description

Inclusion Criteria:

  • Patients with monocular or binocular cataract, lens opacity or abnormal position, need surgery

Exclusion Criteria:

  • The history of systemic diseases and medication affecting vision, diabetic patients with systemic conditions complicated with retinopathy, uncontrolled blood glucose, severe eye diseases, eye trauma, eye surgery, severe dry eye and ocular surface diseases, strabismus and amblyopia were identified

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Senile cataract
Traumatic cataract
Congenital cataract
Lens dislocation group
Complicated cataract

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
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
Uncorrected distance visual acuity
Time Frame: 1 week postoperatively
The UCVA was measured by the same optometrist at each visit
1 week postoperatively
Uncorrected distance visual acuity
Time Frame: 1 month postoperatively
The UCVA was measured by the same optometrist at each visit
1 month postoperatively
Uncorrected distance visual acuity
Time Frame: 3 months postoperatively
The UCVA was measured by the same optometrist at each visit
3 months postoperatively
Intraocular pressure
Time Frame: 1 week postoperatively
Intraocular pressure measured using non-contact tonometer
1 week postoperatively
Intraocular pressure
Time Frame: 1 month postoperatively
Intraocular pressure measured using non-contact tonometer
1 month postoperatively
Intraocular pressure
Time Frame: 3 months postoperatively
Intraocular pressure measured using non-contact tonometer
3 months postoperatively
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
Endothelial cell density
Time Frame: 1 month postoperatively
Endothelial cell density was measured by specular microscopy
1 month postoperatively
Contrast sensitivity
Time Frame: 1 month postoperatively
The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment
1 month postoperatively
Defocusing curve
Time Frame: 1 month postoperatively
From +2.00d to -4.00d, 13 different diopter states were obtained by decreasing the spherical lens degree of +0.50d, and the defocus curve was formed
1 month postoperatively
Stereoscopic vision
Time Frame: 1 month postoperatively
The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles
1 month postoperatively
Glasses usage frequency
Time Frame: 3 months postoperatively
The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%
3 months postoperatively
Optical visual quality questionnaire
Time Frame: 3 months postoperatively
Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)
3 months postoperatively
Visual satisfaction
Time Frame: 3 months postoperatively
The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)
3 months 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.
April 20, 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.
December 31, 2026

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, 2026

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).
April 2, 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.
April 4, 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.
April 6, 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.
May 10, 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.
May 6, 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.
March 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.
  • xuwen2021-0189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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