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

NCT ID: NCT02049333

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phacoemulsification

Cataract extraction alone

Group Type: ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type: PROCEDURE

Phacoemulsification with Endoscopic Cycloplasty (ECPL)

Cataract extraction combined with endoscopic cycloplasty

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Endoscopic Cycloplasty (ECPL)

Intervention Type: PROCEDURE

Interventions

Phacoemulsification

Intervention Type: PROCEDURE

Endoscopic Cycloplasty (ECPL)

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Credit Valley EyeCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Iqbal Ike Ahmed

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ike K Ahmed, MD FRCSC

Role: STUDY_DIRECTOR

University of Toronto, Toronto, Canada

Locations

Osler EyeCare

Brampton, Ontario, Canada

Credit Valley EyeCare

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

ECPLateau10.1

Identifier Type: -

Identifier Source: org_study_id