NCT01468103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

3 years

First QC Date

November 6, 2011

Last Update Submit

November 8, 2011

Conditions

Intraocular Pressure ChangesPeripheral Anterior Synechiae Increasing

Keywords

intraocular pressurePeripheral anterior synechiae

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    3 years

Secondary Outcomes (1)

  • Angle assessment parameters

    3 years

Study Arms (2)

PACS

EXPERIMENTAL

primary angle closure suspects

Procedure: Surgical IridectomyProcedure: Laser Iridotomy

PAC

EXPERIMENTAL

primary angle closure

Procedure: Surgical IridectomyProcedure: Laser Iridotomy

Interventions

Surgical IridectomyPROCEDURE

Surgical Iridectomy is now widely used in our clinical.

Also known as: Peripheral Surgical Iridectomy
PACPACS
Laser IridotomyPROCEDURE

alternative choice to surgical iridectomy

Also known as: Peripheral Laser Iridotomy
PACPACS

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZhongShan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

  • Zhang X Lan, MD

    Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

November 6, 2011

First Posted

November 9, 2011

Study Start

August 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

CN(1)