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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
Sally Williams
Parma, Italy
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
Time frame: 7 years
(a) LogMAR visual acuity, (b) number of cataract extraction procedures
Time frame: 7 years
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