Clinical Trial: Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure With Multi-mechanism Based on UBM: A Randomized Controlled Trial

Brief Summary: This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification.

Detailed Summary:
Sponsor: Sun Yat-sen University

Current Primary Outcome: Progression rate determined by number of patients who progress after laser treatment for each group. [ Time Frame: 3 years ]

PAC progression defined as presence of any of the following:

  1. Acute angle closure crisis
  2. Intraocular (IOP) was 8mmHg higher than initiation 1 month after the laser procedure
  3. IOP was ≥22mmHg when measured three times of continuous 1 month after the lase procedure
  4. The progression of peripheral anterior synechiae ≥ 1 clock hour within 3 years after the laser procedure as measured by gonioscopic examination.
  5. glaucomatous neuropathy within 3 years after the laser procedure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Additional medication or surgery required questionnaire [ Time Frame: 3 years ]
    1. the medication required to control the IOP
    2. the additional surgery required to control the progression of the PAC
  • The change of the best corrected visual acuity after the laser procedure [ Time Frame: 3 years ]
  • The number of the cornea endothelial cells [ Time Frame: 3 years ]
  • The change in angle width and configuration as measured by ultrasound biomicroscopy (UBM) [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: November 5, 2015
Date Started: October 2015
Date Completion: April 2022
Last Updated: November 17, 2016
Last Verified: November 2016