Study on Intraocular Structural Parameters and Surgical E... | NCT04220879

Studies
Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma

NCT04220879

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jan 7, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Glaucoma
Malignant Glaucoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2019Actual

Primary Completion Date

Aug 24, 2020Estimated

Completion Date

Nov 24, 2020Estimated

First Submitted Date

Jan 5, 2020

First Submission Date that Met QC Criteria

Jan 5, 2020

First Posted Date

Jan 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.

Detailed Description

Outcome Measures:

Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malignant Glaucoma		To determine the biometric measurements.
Fellow Eyes		To determine the biometric measurements.
Matched Eyes		To determine the biometric measurements.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trabecular ciliary process angle	TCPA is measured with its apex at the scleral spur, one arm along the posterior corneal surface, and another arm along the most anterior surface of the ciliary body	baseline
Choroidal vascularity parameter	Choroidal vascularity parameter is a vessel ratio measured by optical coherence tomographic images	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: (1) history of operation, (2) diagnosis of MG, and (3) eyes with clear optical media.

Exclusion Criteria:(1)hypertension or diabetes and (2) diagnosis of ocular fundus diseases.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatients >=18 years old with or without malignant glaucoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dingqiao O Wang, M.D	Contact	020-66615461	02066615461	wangdingqiao@163.com
Chengguo O Zuo, M.D,Ph.D	Contact	wangdingqiao@163.com	02066615461	chengguozuo@163.com

Overall Officials

Name	Affiliation	Role
Chengguo O Zuo	Zhognshan Ophthalmic Center, Sun Yat-sen University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhognshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510060	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data (IPD) needed to be keep security.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided