Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02049333|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : January 30, 2014
|Condition or disease||Intervention/treatment|
|Glaucoma||Procedure: Phacoemulsification Procedure: Endoscopic Cycloplasty (ECPL)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||November 2010|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Active Comparator: Phacoemulsification
Cataract extraction alone
Experimental: Phacoemulsification with Endoscopic Cycloplasty (ECPL)
Cataract extraction combined with endoscopic cycloplasty
|Procedure: Phacoemulsification Procedure: Endoscopic Cycloplasty (ECPL)|
- Anterior Chamber Angle Depth (nasal angle) [ Time Frame: Twelve months ]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 ]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 ]IOP will be recorded and compared to pre-operative IOP.
- Intra- and post-operative complications [ Time Frame: Up to one year after surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|