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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Phacoemulsification; Procedure: Endoscopic Cycloplasty (ECPL)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6V 1B4
      • Osler Eyecare
    • Mississauga, Ontario, Canada, L5L 1W8
      • Credit Valley EyeCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Angle Depth (nasal angle)	Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging	Twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of glaucoma medications	The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.	Twelve months post-op
Intraocular pressure (IOP)	IOP will be recorded and compared to pre-operative IOP.	Twelve months post-op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and post-operative complications	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.	Up to one year after surgery

Collaborators and Investigators

• Sponsor: Credit Valley EyeCare
• Investigators: Study Director: Ike K Ahmed, MD FRCSC, University of Toronto, Toronto, Canada

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (ESTIMATE): January 30, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 30, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: ECPLateau10.1