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

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

Condition Intervention
Glaucoma Procedure: Phacoemulsification Procedure: Endoscopic Cycloplasty (ECPL)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study

Resource links provided by NLM:

Further study details as provided by Iqbal Ike Ahmed, Credit Valley EyeCare:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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.

Enrollment: 26
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phacoemulsification
Cataract extraction alone
Procedure: Phacoemulsification
Experimental: Phacoemulsification with Endoscopic Cycloplasty (ECPL)
Cataract extraction combined with endoscopic cycloplasty
Procedure: Phacoemulsification Procedure: Endoscopic Cycloplasty (ECPL)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT02049333

Canada, Ontario
Osler EyeCare
Brampton, Ontario, Canada, L6V 1B4
Credit Valley EyeCare
Mississauga, Ontario, Canada, L5L 1W8
Sponsors and Collaborators
Credit Valley EyeCare
Study Director: Ike K Ahmed, MD FRCSC University of Toronto, Toronto, Canada
  More Information

Responsible Party: Iqbal Ike Ahmed, MD, Credit Valley EyeCare Identifier: NCT02049333     History of Changes
Other Study ID Numbers: ECPLateau10.1
Study First Received: January 27, 2014
Last Updated: January 29, 2014 processed this record on September 21, 2017