Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gao Xinbo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01468103
First received: November 6, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Intraocular Pressure Changes
Peripheral Anterior Synechiae Increasing
Procedure: Surgical Iridectomy
Procedure: Laser Iridotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angle assessment parameters [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.


Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PACS
primary angle closure suspects
Procedure: Surgical Iridectomy
Surgical Iridectomy is now widely used in our clinical.
Other Name: Peripheral Surgical Iridectomy
Procedure: Laser Iridotomy
alternative choice to surgical iridectomy
Other Name: Peripheral Laser Iridotomy
Experimental: PAC
primary angle closure
Procedure: Surgical Iridectomy
Surgical Iridectomy is now widely used in our clinical.
Other Name: Peripheral Surgical Iridectomy
Procedure: Laser Iridotomy
alternative choice to surgical iridectomy
Other Name: Peripheral Laser Iridotomy

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.
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468103

Locations
China, Guang Dong Province
ZhongShan Ophthalmic Center Recruiting
GuangZhou, Guang Dong Province, China, 510060
Contact: Gao Xinbo, MD       ice.freeport@163.com   
Principal Investigator: Gao Xinbo, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Zhang X Lan, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Gao Xinbo, student, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01468103     History of Changes
Other Study ID Numbers: 19831105gaoxinbo
Study First Received: November 6, 2011
Last Updated: November 8, 2011
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
intraocular pressure
Peripheral anterior synechiae

ClinicalTrials.gov processed this record on November 19, 2014