A Comparison Between Deep Sclerectomy and Trabeculectomy
- Conditions
- Glaucoma
- Interventions
- Procedure: trabeculectomyProcedure: deep sclerectomy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TE trabeculectomy trabeculectomy DS deep sclerectomy deep sclerectomy
- 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