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CompletedNCT02049333Updated Jan 30, 2014

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

An interventional study of Phacoemulsification and Endoscopic Cycloplasty (ECPL) in Glaucoma, sponsored by Credit Valley EyeCare. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-30.

Sponsored by Credit Valley EyeCare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.

This study's enrollment of 26 is below the median of 65 across 1,296 interventional studies indexed under Glaucoma.

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Lead sponsor

Credit Valley EyeCare is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
26 participants (actual)

Study arms

  • 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)

Interventions

  • ProcedurePhacoemulsification
  • ProcedureEndoscopic Cycloplasty (ECPL)
06

What researchers measure

Primary outcomes

  1. Anterior Chamber Angle Depth (nasal angle)

    Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging

    Time frame: Twelve months

Secondary outcomes

  1. Number of glaucoma medications

    The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.

    Time frame: Twelve months post-op

  2. Intraocular pressure (IOP)

    IOP will be recorded and compared to pre-operative IOP.

    Time frame: Twelve months post-op

Other outcomes

  1. 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.

    Time frame: Up to one year after surgery

07

Study locations

2 sites
  • Osler EyeCare
    Brampton, Ontario L6V 1B4, Canada
  • Credit Valley EyeCare
    Mississauga, Ontario L5L 1W8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Nov 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2014
First posted
Jan 30, 2014
Start
Nov 2010
Primary completionActual
Nov 2013
CompletionActual
Nov 2013
Last update
Jan 30, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02049333
Lead sponsor
Credit Valley EyeCare
Responsible party
Iqbal Ike Ahmed (MD, Credit Valley EyeCare) — Principal investigator
First posted
Jan 30, 2014
Start date
Nov 2010
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jan 30, 2014

Study contacts

Ike K Ahmed, MD FRCSC
study director · University of Toronto, Toronto, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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