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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phacoemulsification
Endoscopic Cycloplasty (ECPL)
Sponsored by
Credit Valley EyeCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osler EyeCare
  • Credit Valley EyeCare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Phacoemulsification

Phacoemulsification with Endoscopic Cycloplasty (ECPL)

Arm Description

Cataract extraction alone

Cataract extraction combined with endoscopic cycloplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of glaucoma medications
The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.
Intraocular pressure (IOP)
IOP will be recorded and compared to pre-operative IOP.

Full Information

First Posted
January 27, 2014
Last Updated
January 29, 2014
Sponsor
Credit Valley EyeCare
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1. Study Identification

Unique Protocol Identification Number
NCT02049333
Brief Title
Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
Official Title
Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Credit Valley EyeCare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phacoemulsification
Arm Type
Active Comparator
Arm Description
Cataract extraction alone
Arm Title
Phacoemulsification with Endoscopic Cycloplasty (ECPL)
Arm Type
Experimental
Arm Description
Cataract extraction combined with endoscopic cycloplasty
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Cycloplasty (ECPL)
Primary Outcome Measure Information:
Title
Anterior Chamber Angle Depth (nasal angle)
Description
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Number of glaucoma medications
Description
The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.
Time Frame
Twelve months post-op
Title
Intraocular pressure (IOP)
Description
IOP will be recorded and compared to pre-operative IOP.
Time Frame
Twelve months post-op
Other Pre-specified Outcome Measures:
Title
Intra- and post-operative complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ike K Ahmed, MD FRCSC
Organizational Affiliation
University of Toronto, Toronto, Canada
Official's Role
Study Director
Facility Information:
Facility Name
Osler EyeCare
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6V 1B4
Country
Canada
Facility Name
Credit Valley EyeCare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada

12. IPD Sharing Statement

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

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