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Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

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ClinicalTrials.gov Identifier: NCT01468103
Recruitment Status : Unknown
Verified November 2011 by Gao Xinbo, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Gao Xinbo, Sun Yat-sen University

November 6, 2011
November 9, 2011
November 9, 2011
August 2009
August 2012   (Final data collection date for primary outcome measure)
intraocular pressure [ Time Frame: 3 years ]
Same as current
No Changes Posted
Angle assessment parameters [ Time Frame: 3 years ]
Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.
Same as current
Not Provided
Not Provided
 
Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure
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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Intraocular Pressure Changes
  • Peripheral Anterior Synechiae Increasing
  • 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: PACS
    primary angle closure suspects
    Interventions:
    • Procedure: Surgical Iridectomy
    • Procedure: Laser Iridotomy
  • Experimental: PAC
    primary angle closure
    Interventions:
    • Procedure: Surgical Iridectomy
    • Procedure: Laser Iridotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Same as current
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01468103
19831105gaoxinbo
No
Not Provided
Not Provided
Gao Xinbo, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Director: Zhang X Lan, MD Sun Yat-sen University
Sun Yat-sen University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP