NCT02049333

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

January 27, 2014

Last Update Submit

January 29, 2014

Conditions

Glaucoma

Outcome Measures

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

    Twelve months

Secondary Outcomes (2)

  • Number of glaucoma medications

    Twelve months post-op

  • Intraocular pressure (IOP)

    Twelve months post-op

Other Outcomes (1)

  • Intra- and post-operative complications

    Up to one year after surgery

Study Arms (2)

Phacoemulsification

ACTIVE COMPARATOR

Cataract extraction alone

Procedure: Phacoemulsification

Phacoemulsification with Endoscopic Cycloplasty (ECPL)

EXPERIMENTAL

Cataract extraction combined with endoscopic cycloplasty

Procedure: PhacoemulsificationProcedure: Endoscopic Cycloplasty (ECPL)

Interventions

PhacoemulsificationPROCEDURE
PhacoemulsificationPhacoemulsification with Endoscopic Cycloplasty (ECPL)
Endoscopic Cycloplasty (ECPL)PROCEDURE
Phacoemulsification with Endoscopic Cycloplasty (ECPL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osler EyeCare

Brampton, Ontario, L6V 1B4, Canada

Location

Credit Valley EyeCare

Mississauga, Ontario, L5L 1W8, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Ike K Ahmed, MD FRCSC

    University of Toronto, Toronto, Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 30, 2014

Study Start

November 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

CA(2)