Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	March 4, 2008
Last Updated Date	June 12, 2008
Start Date ^†	March 2005
Current Primary Outcome Measures ^† (submitted: June 16, 2008)	Mean IOP and surgical success rates. na [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00698438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study
Official Title ^†	Prospective, Randomized Clinical Trial,to Compare Standard Trabeculectomy to the Ex-PRESS Mini Glaucoma Shunt Implantation Under a Scleral Flap in Eyes With Open-Angle Glaucoma
Brief Summary	the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this report, we describe the results of a prospective, randomized trial in which subjects with bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design: Prospective, randomized clinical trial. Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two years. Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was also similar at all time points except postoperative day 1, when trabeculectomy eyes were lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without medications) and qualified (with or without medications) successes were more common at all IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015 respectively). Postoperative complications were uncommon in both groups, but trabeculectomy eyes required more postoperative interventions than Ex-PRESS eyes.
Detailed Description
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Condition ^†	Glaucoma
Intervention ^†	Device: Ex-PRESS implantation Procedure: Trabeculectomy
Study Arms / Comparison Groups	Active Comparator: Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap Active Comparator: Trabecolectomy
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	30
Completion Date
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Subjects were at least 18 years of age and Had medically uncontrolled primary open-angle glaucoma requiring incisional surgery for reduction of intraocular pressure in both eyes. Subjects with prior cataract or failed filtration surgery in either eye were eligible to participate if surgery occurred at least 3 months prior to enrollment. Exclusion Criteria: Any form of glaucoma other than primary open-angle glaucoma; History of or active uveitis; or Any ocular abnormality that would prevent accurate assessment of intraocular pressure
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	South Africa
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00698438
Responsible Party	Elie Dahan
Secondary IDs ^††
Study Sponsor ^†	University of Witwatersrand, South Africa
Collaborators ^††
Investigators ^†
Information Provided By	University of Witwatersrand, South Africa
Verification Date	June 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.