Assessment Of Anterior Chamber Configuration Changes Afte... | NCT03779542

Status Module

Record Verification Date

Dec 2018

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

Jan 1, 2018Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 2019Estimated

First Submitted Date

Dec 17, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 2018Actual

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

Dec 17, 2018

Last Update Posted Date

Dec 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To assess the changes of anterior chamber angle in patients with shallow anterior chamber and normal anterior chamber after phacoemulsification and intraocular lens implantation (IOL) using anterior segment swept-source optical coherence tomography (AS-SS-OCT).To observe the 60 eyes of 60 patients in our study.

Detailed Description

This is a prospective case-control study; 60 eyes of 60 patients who underwent cataract surgery. Based on anterior chamber depth (ACD) and gonioscopy findings, the eyes are classified into two groups, shallow anterior chamber group (30 eyes) and narrow anterior chamber group (30 eyes). AS-SS-OCT was used to measure ACD and angle parameters (angle opening distance(AOD), angle recess area(ARA), trabecular iris space area（TISA）, and trabecular iris angle (TIA). Serial changes in each group were measured before and 3 months after phacoemulsification and IOL, and the differences between the two groups were compared.

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
open-angle group		ACD > 2.68 measured by the swept source AS-OCT and angle > Shaffer 2 in four quadrants under gonioscope	Procedure: cataract surgery
narrow-angle group		ACD≤2.68 measured by the swept source AS-OCT and angle≤Shaffer 2 in four quadrants under gonioscope	Procedure: cataract surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery	Procedure	phacoemulsification and intraocular lens implantation	narrow-angle group open-angle group

Measure	Description	Time Frame
anterior chamber depth		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria: patients who underwent cataract surgery -

Exclusion Criteria:patients with mild cataracts do not require surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients who underwent cataract surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Man Hu, MD	Contact	+86-0571-88185666		64344308@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Wenzhou Medical College	Recruiting	Wenzhou	Zhejiang	325027	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative