Evaluation of Filtering Bleb After Glaucoma Surgery by AS-OCTA (AS-OCTA)

August 12, 2020 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study on the Value and Mechanism of AS-OCTA in the Evaluation of Filtering Bleb Function and Outcome After Glaucoma Surgery

When antihypertensive drugs or laser therapy can not reach the target intraocular pressure, trabeculectomy (TRAB) is still the standard surgical method for glaucoma. The scarring of the operative area is a common reason for the failure of trabeculectomy. After trabeculectomy, maintaining the shape and function of the filtering bleb is an important aspect to maintain the surgical effect. The increase in the number of blood vessels on the filtering bleb and the morphological curvature are often the manifestations of decompensation of the filtering bleb. Angiogenesis in the filtering bleb region plays an important role in surgical incision healing and is related to the accompanying scar formation. Therefore, the evaluation of vascular distribution of filtering blebs is an important index and early parameter to evaluate the success or failure of surgery. With the improvement of detection methods, it is possible to use AS-OCTA to evaluate the function and prognosis of filtering bleb after trabeculectomy. Antimitotic drugs such as 5-fluorouracil (5-FU) or mitomycin C (MMC) have always been the most commonly used clinical drugs, but the side effects caused by their use are not satisfactory. It is still the research direction of glaucoma to find new targets for regulating wound healing and more safe and effective drugs.

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

Glaucoma is a group of optic nerve diseases characterized by progressive and irreversible degeneration of retinal ganglion cells and their axons. Retinal ganglion cells, RGCs is a kind of central nervous system neuron whose cell bodies are located in the retina and axons make up the optic nerve. When antihypertensive drugs or laser therapy can not reach the target intraocular pressure, trabeculectomy (TRAB) is still the standard surgical method for glaucoma. The scarring of the operative area is a common reason for the failure of trabeculectomy. After trabeculectomy, maintaining the shape and function of the filtering bleb is an important aspect to maintain the surgical effect. The increase in the number of blood vessels on the filtering bleb and the morphological curvature are often the manifestations of decompensation of the filtering bleb. Angiogenesis in the filtering bleb region plays an important role in surgical incision healing and is related to the accompanying scar formation. Therefore, the evaluation of vascular distribution of filtering blebs is an important index and early parameter to evaluate the success or failure of surgery. With the improvement of detection methods, it is possible to use AS-OCTA to evaluate the function and prognosis of filtering bleb after trabeculectomy. Antimitotic drugs such as 5-fluorouracil (5-FU) or mitomycin C (MMC) have always been the most commonly used clinical drugs, but the side effects caused by their use are not satisfactory. It is still the research direction of glaucoma to find new targets for regulating wound healing and more safe and effective drugs.

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.
50

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 Contact Backup

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients preparing for trabeculectomy for glaucoma

Description

Inclusion Criteria:

  1. Those who are over 18 years old and can complete all the tests and examinations.
  2. Patients who want to undergo trabeculectomy in accordance with the diagnosis of glaucoma.
  3. Intraocular pressure can not be controlled by intraocular pressure lowering drugs and laser therapy (intraocular pressure can not be controlled ≤ 21mmHg).

Exclusion Criteria:

  1. Those with a history of ocular trauma, trabeculectomy within 6 months, eye surgery or eye laser within 3 years.
  2. The conjunctival state of the proposed surgical area can not support high-quality imaging (signal intensity < 6).
  3. Postoperative conjunctival hemorrhage or serious complications, including hyphema, malignant glaucoma, endophthalmitis and so on.
  4. The condition of the whole body does not support surgery, such as heart disease, mental illness, malignant tumor, etc.
  5. After trabeculectomy, glaucoma drug treatment or reoperation was performed.
  6. Pregnant, lactating and pregnant women. Those who refuse to sign the informed consent form or voluntarily withdraw from the study due to discomfort or other reasons.

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: Case-Only
  • Time Perspectives: Prospective

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
Changes in the results of baseline AS-OCTA at different points in time
Time Frame: AS-OCTA was performed before operation, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
AS-OCTA
AS-OCTA was performed before operation, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.

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
Vision
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of visual acuity at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Slit lamp microscope
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of baseline slit lamp microscope at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Anterior segment photography
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Photographic changes of anterior segment at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Intraocular pressure
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of intraocular pressure at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Anterior chamber gonioscope
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of anterior chamber gonioscope at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
UBM
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
UBM changes at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
fundus color photography
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of fundus color photography at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
A ultrasound
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of A-ultrasound at baseline and at different times
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
B ultrasound
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of B-ultrasound at baseline and at different times
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
visual field
Time Frame: The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Changes of visual field at baseline and at different time points
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.

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

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

Helpful Links

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.
September 1, 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.
August 30, 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.
August 30, 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).
August 5, 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 12, 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 17, 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 17, 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 12, 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.
  • 2020KYPJ119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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