Laser Iridotomy Versus Surgical Iridectomy in Early Angle... | NCT01468103

Studies
Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

NCT01468103

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Nov 9, 2011Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Intraocular Pressure Changes
Peripheral Anterior Synechiae Increasing

Interventions

Surgical Iridectomy
Laser Iridotomy

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

Nov 2011

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

Aug 2009

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Nov 6, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 9, 2011Estimated

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

Nov 8, 2011

Last Update Posted Date

Nov 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.

Detailed Description

The following will be studied:

To evaluate the safety of these two techniques for the treatment of angle closure.
To compare the anterior chamber reaction and IOP changes post surgery.
TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.
To assess the development of PAS.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PACS	Experimental	primary angle closure suspects	Procedure: Surgical Iridectomy Procedure: Laser Iridotomy
PAC	Experimental	primary angle closure	Procedure: Surgical Iridectomy Procedure: Laser Iridotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical Iridectomy	Procedure	Surgical Iridectomy is now widely used in our clinical.	PAC PACS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraocular pressure		3 years

Secondary Outcomes

Measure	Description	Time Frame
Angle assessment parameters	Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 50 years old
Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
Able to give Informed concent

Exclusion Criteria:

Ophthalmic diseases other than glaucoma and cataract
pseudophakic or aphakic patients
inability to attend regular follow-up assessment or to give informed written consent
Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
Participating in another study
monocular patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhang X Lan, MD	Sun Yat-sen University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ZhongShan Ophthalmic Center	Recruiting	Guangzhou	Guangdong	510060	China