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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iqbal Ike Ahmed, Credit Valley EyeCare
ClinicalTrials.gov Identifier:
NCT02049333
First received: January 27, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Credit Valley EyeCare:

Primary Outcome Measures:
  • Anterior Chamber Angle Depth (nasal angle) [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT02049333

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

No publications provided

Responsible Party: Iqbal Ike Ahmed, MD, Credit Valley EyeCare
ClinicalTrials.gov Identifier: NCT02049333     History of Changes
Other Study ID Numbers: ECPLateau10.1
Study First Received: January 27, 2014
Last Updated: January 29, 2014
Health Authority: Canada: Canadian Food & Drug Act & Regulations

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014