Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
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.
Procedure: Endoscopic Cycloplasty (ECPL)
|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|
- 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
- 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.
- 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.
|Study Start Date:||November 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Phacoemulsification
Cataract extraction alone
Experimental: Phacoemulsification with Endoscopic Cycloplasty (ECPL)
Cataract extraction combined with endoscopic cycloplasty
|Procedure: Phacoemulsification Procedure: Endoscopic Cycloplasty (ECPL)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049333
|Brampton, Ontario, Canada, L6V 1B4|
|Credit Valley EyeCare|
|Mississauga, Ontario, Canada, L5L 1W8|
|Study Director:||Ike K Ahmed, MD FRCSC||University of Toronto, Toronto, Canada|