A Comparison Between Deep Sclerectomy and Trabeculectomy

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT00595855
• Lead Sponsor: University of Parma

Brief 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

Study Timeline

• Study Start: 1997-10
• Study Completion: 2006-12
• Primary Completion: 2007-01
• Status Verified: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Last Update Submitted: 2008-01-07
• Study First Posted: 2008-01-16
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Angle wide open
• Age > 65 yrs
• IOP > 23 and < 30 mmHg (average of the two highest readings of the daily IOP phasing)
• Topical beta blocker in fellow eye
• At least two medications in use + previous ALT
• MD < 20 dB (HFA 24-2 full threshold)
• LOCSII < C1-N1-P0

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)	7 years

Secondary Outcome Measures

Name	Time	Method
(a) LogMAR visual acuity, (b) number of cataract extraction procedures	7 years

Trial Locations

Locations (1)

Sally Williams; 🇮🇹 Parma, Italy