We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02049333
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Information provided by (Responsible Party):

January 27, 2014
January 30, 2014
January 30, 2014
November 2010
November 2013   (Final data collection date for primary outcome measure)
Anterior Chamber Angle Depth (nasal angle) [ Time Frame: Twelve months ]
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
Same as current
No Changes Posted
  • Number of glaucoma medications [ Time Frame: Twelve months post-op ]
    The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.
  • Intraocular pressure (IOP) [ Time Frame: Twelve months post-op ]
    IOP will be recorded and compared to pre-operative IOP.
Same as current
Intra- and post-operative complications [ Time Frame: Up to one year after surgery ]
Analyzing any unexpected complications from the surgery such as prolonged hypotony, intraocular pressure spike, prolonged corneal inflammation etc. This will be done during the clinic visit and analyzed under slit lamp examination.
Same as current
Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Procedure: Phacoemulsification
  • Procedure: Endoscopic Cycloplasty (ECPL)
  • Active Comparator: Phacoemulsification
    Cataract extraction alone
    Intervention: Procedure: Phacoemulsification
  • Experimental: Phacoemulsification with Endoscopic Cycloplasty (ECPL)
    Cataract extraction combined with endoscopic cycloplasty
    • Procedure: Phacoemulsification
    • Procedure: Endoscopic Cycloplasty (ECPL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2013
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has to be ≥ 18 years of age of either gender
  • Nuclear sclerotic cataract graded by LOCS III to be < 5
  • Diagnosis of Plateau Iris Configuration or Syndrome
  • No contraindication for cataract or ECPL operation
  • Written informed consent on IRB approved Informed Consent Form

Exclusion Criteria:

  • Hard cataracts, LOCS III 5 and 6
  • Ciliary body cysts
  • Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
  • Congenital anomaly of the irido-trabecular angle
  • Previous intraocular surgery
  • Previous laser gonioplasty to either eye
  • Placement of the intraocular lens in any place other than the capsular bag
  • Pupilloplasty
  • Rubeosis
  • Peripheral anterior synechiae (PAS) nasal angle and/or >180 degrees of PAS
  • Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders
  • Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
  • Corneal opacities or disorders that would inhibit visualization of the nasal angle
  • Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes
  • Inability to attend regular follow-up assessment or to give informed written consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Iqbal Ike Ahmed, Credit Valley EyeCare
Credit Valley EyeCare
Not Provided
Study Director: Ike K Ahmed, MD FRCSC University of Toronto, Toronto, Canada
Credit Valley EyeCare
January 2014

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