NCT00595855

A Comparison Between Deep Sclerectomy and Trabeculectomy

Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.

Detailed description

Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5% Methods and evaluation of outcomes: 1. IOP: average of the two highest readings of the IOP phasing (6 readings) 2. VA: LogMAR (ETDRS chart) 3. Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits study visits: every 4 months

Conditions

• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	trabeculectomy	Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis
PROCEDURE	deep sclerectomy	deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)

Timeline

• Start date: 1997-10-01
• Primary completion: 2007-01-01
• Completion: 2006-12-01
• First posted: 2008-01-16
• Last updated: 2008-01-16

Locations

1 site across 1 country: Italy