Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
Not Applicable
Completed
- Conditions
- Glaucoma
- Interventions
- Procedure: PhacoemulsificationProcedure: Endoscopic Cycloplasty (ECPL)
- Registration Number
- NCT02049333
- Lead Sponsor
- Credit Valley EyeCare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phacoemulsification Phacoemulsification Cataract extraction alone Phacoemulsification with Endoscopic Cycloplasty (ECPL) Phacoemulsification Cataract extraction combined with endoscopic cycloplasty Phacoemulsification with Endoscopic Cycloplasty (ECPL) Endoscopic Cycloplasty (ECPL) Cataract extraction combined with endoscopic cycloplasty
- Primary Outcome Measures
Name Time Method Anterior Chamber Angle Depth (nasal angle) Twelve months Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
- Secondary Outcome Measures
Name Time Method Number of glaucoma medications Twelve months post-op The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.
Intraocular pressure (IOP) Twelve months post-op IOP will be recorded and compared to pre-operative IOP.
Trial Locations
- Locations (2)
Credit Valley EyeCare
🇨🇦Mississauga, Ontario, Canada
Osler EyeCare
🇨🇦Brampton, Ontario, Canada