A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy

August 4, 2020 updated by: Xi Shen, Ruijin Hospital

A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing 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.

Detailed Description

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) 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.
Observational

Enrollment (Actual)

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.
46

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
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients

Description

Inclusion Criteria:

  • aged⩾40years; intraocular pressure (IOP) < 21 mm Hg in both eyes, spherical refractive error<6 diopters spherical equivalent.

Exclusion Criteria:

  • previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.

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

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.
control
the age-related cataract patients
DR group
the cataract patients with mild/moderate NPDR

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
CVI at baseline
Time Frame: CVI was assessed at baseline(within 1 week before surgery)
choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI was assessed at baseline(within 1 week before surgery)
CVI at 1 week postoperatively
Time Frame: CVI was assessed 1 week after surgery.
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI was assessed 1 week after surgery.
CVI at 1 month postoperatively
Time Frame: CVI was assessed 1 month after surgery.
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI was assessed 1 month after surgery.
CVI at 3 months postoperatively
Time Frame: CVI was assessed 3 months after surgery.
choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.
CVI was assessed 3 months after surgery.
CT at baseline
Time Frame: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
CT at 1 week postoperatively
Time Frame: CT was assessed at 1 week after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT was assessed at 1 week after surgery.
CT at 1 month postoperatively
Time Frame: CT was assessed at 1 month after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT was assessed at 1 month after surgery.
CT at 3 months postoperatively
Time Frame: CT was assessed at 3 months after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.
CT was assessed at 3 months after surgery.
VD at baseline
Time Frame: VD of the choriocapillaris was assessed at baseline.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD of the choriocapillaris was assessed at baseline.
VD at 1 week postoperatively
Time Frame: VD of the choriocapillaris was assessed 1 week after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD of the choriocapillaris was assessed 1 week after surgery.
VD at 1 month postoperatively
Time Frame: VD of the choriocapillaris was assessed 1 month after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD of the choriocapillaris was assessed 1 month after surgery.
VD at 3 months postoperatively
Time Frame: VD of the choriocapillaris was assessed 3 months after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid
VD of the choriocapillaris was assessed 3 months after 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
IOP at baseline
Time Frame: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
IOP was the value of intraocular pressure.
IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
IOP at 1 week postoperatively
Time Frame: IOP was assessed 1 week after surgery.
IOP was the value of intraocular pressure .
IOP was assessed 1 week after surgery.
IOP at 1 month postoperatively
Time Frame: IOP was assessed 1 month after surgery.
IOP was the value of intraocular pressure.
IOP was assessed 1 month after surgery.
IOP at 3 months postoperatively
Time Frame: IOP was assessed 3 months after surgery.
IOP was the value of intraocular pressure .
IOP was assessed 3 months after surgery.
BCVA at baseline
Time Frame: BCVA was assessed at baseline .
BCVA was the best corrected visual acuity.
BCVA was assessed at baseline .
BCVA at 3 months postoperatively
Time Frame: BCVA was assessed 3 months after surgery.
BCVA was the best corrected visual acuity.
BCVA was assessed 3 months 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.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xi Shen, PhD, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2018

Primary Completion (Actual)

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.
October 30, 2019

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 30, 2020

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 30, 2020

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.
August 4, 2020

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.
August 5, 2020

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.
August 5, 2020

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.
August 4, 2020

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.
August 1, 2020

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.
  • 2018ZY14

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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