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

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iqbal Ike Ahmed, Credit Valley EyeCare
ClinicalTrials.gov Identifier:
NCT02049333
First received: January 27, 2014
Last updated: January 29, 2014
Last verified: January 2014

January 27, 2014
January 29, 2014
November 2010
November 2013   (final data collection date for primary outcome measure)
Anterior Chamber Angle Depth (nasal angle) [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
Same as current
Complete list of historical versions of study NCT02049333 on ClinicalTrials.gov Archive Site
  • Number of glaucoma medications [ Time Frame: Twelve months post-op ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Glaucoma
  • 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
    Interventions:
    • 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.
 
Completed
26
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT02049333
ECPLateau10.1
No
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