Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

November 8, 2011 updated by: Gao Xinbo, Sun Yat-sen University

Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The following will be studied:

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guang Dong Province
      • GuangZhou, Guang Dong Province, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:
        • Principal Investigator:
          • Gao Xinbo, MD

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

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PACS
primary angle closure suspects
Procedure: Surgical Iridectomy
Surgical Iridectomy is now widely used in our clinical.
Other Names:
  • Peripheral Surgical Iridectomy
Procedure: Laser Iridotomy
alternative choice to surgical iridectomy
Other Names:
  • Peripheral Laser Iridotomy
EXPERIMENTAL: PAC
primary angle closure
Procedure: Surgical Iridectomy
Surgical Iridectomy is now widely used in our clinical.
Other Names:
  • Peripheral Surgical Iridectomy
Procedure: Laser Iridotomy
alternative choice to surgical iridectomy
Other Names:
  • Peripheral Laser Iridotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Zhang X Lan, MD, Sun Yat-sen University

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

August 1, 2009

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

November 6, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (ESTIMATE)

November 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19831105gaoxinbo

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.

Clinical Trials on Intraocular Pressure Changes

Clinical Trials on Surgical Iridectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe