A Comparison Between Deep Sclerectomy and Trabeculectomy

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

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.

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

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